Richard Pazdur

Q: What Schools Are Affiliated With Richard Pazdur

Richard Pazdur is affiliated with the following schools: MD Anderson Cancer Center, University of Edinburgh, Baylor University

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Richard Pazdur

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#2367

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According to Wikipedia, Richard Pazdur is an American oncologist serving as the founding director of the Oncology Center of Excellence within the Food and Drug Administration. He was appointed to the position in 2005. He was previously the director of the FDA's Office of Hematology Oncology Products from 1999 to 2005.

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Richard Pazdur's Published Works

Number of citations in a given year to any of this author's works

Total number of citations to an author for the works they published in a given year. This highlights publication of the most important work(s) by the author

Published Works

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis (2014) (2895)
FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma. (2007) (1115)
Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. (2001) (825)
Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapy. (2003) (602)
FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors (2019) (591)
FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome (2018) (591)
FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme. (2009) (564)
FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets. (2003) (530)
Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration. (2004) (529)
United States Food and Drug Administration Drug Approval Summary (2004) (500)
Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia. (2002) (467)
End points and United States Food and Drug Administration approval of oncology drugs. (2003) (463)
Approval Summary: Sunitinib for the Treatment of Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma (2007) (451)
Tumor downstaging and sphincter preservation with preoperative chemoradiation in locally advanced rectal cancer: the M. D. Anderson Cancer Center experience. (1999) (443)
Sorafenib for the Treatment of Advanced Renal Cell Carcinoma (2006) (418)
First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication. (2017) (416)
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy (2015) (412)
FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension. (2005) (408)
Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. (1998) (398)
FDA drug approval summary: erlotinib (Tarceva) tablets. (2005) (379)
Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes (2005) (371)
Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors. (2002) (370)
FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer. (2007) (370)
FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease (2010) (356)
FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy (2016) (356)
Capecitabine, an oral fluoropyrimidine carbamate with substantial activity in advanced colorectal cancer: results of a randomized phase II study. (2000) (341)
Approval Summary for Bortezomib for Injection in the Treatment of Multiple Myeloma (2004) (318)
United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy (2006) (315)
Pathological complete response and accelerated drug approval in early breast cancer. (2012) (315)
The taxoids: paclitaxel (Taxol) and docetaxel (Taxotere). (1993) (283)
Improved Overall Survival Among Responders to Preoperative Chemoradiation for Locally Advanced Rectal Cancer (2001) (280)
FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1 (2016) (277)
Activity of taxol in patients with squamous cell carcinoma and adenocarcinoma of the esophagus. (1994) (252)
FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL). (2007) (250)
Endpoints for assessing drug activity in clinical trials. (2008) (246)
Vorinostat for Treatment of Cutaneous Manifestations of Advanced Primary Cutaneous T-Cell Lymphoma (2007) (246)
Food and Drug Administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma. (2007) (243)
Response to neoadjuvant chemotherapy best predicts survival after curative resection of gastric cancer. (1999) (242)
FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2. (2008) (241)
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer (2015) (234)
Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate (2008) (234)
FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (2015) (231)
Phase II trial of uracil and tegafur plus oral leucovorin: an effective oral regimen in the treatment of metastatic colorectal carcinoma. (1994) (227)
FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements. (2014) (224)
FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer (2014) (219)
Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives. (2003) (215)
FDA Approval: Blinatumomab (2015) (214)
Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus. (1998) (207)
FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma. (2010) (207)
Approval Summary for Erlotinib for Treatment of Patients with Locally Advanced or Metastatic Non–Small Cell Lung Cancer after Failure of at Least One Prior Chemotherapy Regimen (2005) (206)
U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. (2005) (204)
Real-world Data for Clinical Evidence Generation in Oncology. (2017) (203)
Accelerated approval of oncology products: the food and drug administration experience. (2011) (199)
Bortezomib for the Treatment of Mantle Cell Lymphoma (2007) (199)
Cancer Management: A Multidisciplinary Approach (2007) (198)
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond (2017) (196)
Multimodal therapy for limited small-cell lung cancer: a randomized study of induction combination chemotherapy with or without thoracic radiation in complete responders; and with wide-field versus reduced-field radiation in partial responders: a Southwest Oncology Group Study. (1987) (196)
A multicenter, Phase II trial of weekly irinotecan (CPT‐11) in patients with previously treated colorectal carcinoma (1999) (195)
FDA drug approval summary: panitumumab (Vectibix). (2007) (194)
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms (2016) (192)
Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases. (2003) (188)
FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer. (2007) (185)
U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma (2013) (176)
A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review (2018) (173)
U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma (2012) (172)
Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses. (2015) (166)
Phase II study of Taxol in patients with advanced gastric carcinoma. (1998) (159)
Anticancer drug discovery and development throughout the world. (2002) (156)
FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia (2018) (156)
FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase–Positive Non–Small Cell Lung Cancer (2015) (155)
FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation (2014) (150)
FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation–Positive Non–Small Cell Lung Cancer (2016) (149)
FDA drug approval summaries: oxaliplatin. (2004) (149)
Prognostic implications of response to preoperative infusional chemoradiation in locally advanced rectal cancer. (1999) (149)
Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody. (2019) (148)
The risks and benefits of 5α-reductase inhibitors for prostate-cancer prevention. (2011) (145)
FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1 (2018) (145)
Comparison of 5-fluorouracil pharmacokinetics in patients receiving continuous 5-fluorouracil infusion and oral uracil plus N1-(2'-tetrahydrofuryl)-5-fluorouracil. (1998) (144)
CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. (2019) (143)
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy (2017) (140)
Phase I trial of Taxotere: five-day schedule. (1992) (140)
Phase II study of fluorouracil and recombinant interferon alfa-2a in previously untreated advanced colorectal carcinoma. (1990) (138)
FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations (2018) (138)
FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia (2018) (136)
FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma (2018) (133)
Food and Drug Administration Drug Approval Summary: Temozolomide Plus Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (2005) (132)
Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer. (2019) (132)
U.S. Food and Drug Administration Approval: Crizotinib for Treatment of Advanced or Metastatic Non–Small Cell Lung Cancer That Is Anaplastic Lymphoma Kinase Positive (2014) (130)
First FDA Approval of Neoadjuvant Therapy for Breast Cancer: Pertuzumab for the Treatment of Patients with HER2-Positive Breast Cancer (2014) (130)
Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary (2012) (129)
Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib (2008) (127)
FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (2018) (127)
Sorafenib for the treatment of unresectable hepatocellular carcinoma. (2009) (126)
U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma (2013) (125)
FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia. (2018) (123)
Preoperative radiation and chemotherapy for localized squamous cell carcinoma of the esophagus: a RTOG Study. (1988) (123)
FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma (2015) (121)
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy (2018) (119)
FDA drug approval summaries: pemetrexed (Alimta). (2004) (117)
U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations. (2014) (115)
FDA report: eculizumab (Soliris) for the treatment of patients with paroxysmal nocturnal hemoglobinuria. (2008) (115)
Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors. (2009) (113)
FDA Approval Summary: Nivolumab for the Treatment of Relapsed or Progressive Classical Hodgkin Lymphoma (2017) (113)
FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors. (2012) (113)
FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation (2010) (113)
Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary (2013) (109)
FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy (2017) (109)
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation–Associated Advanced Ovarian Cancer (2017) (108)
Pemetrexed in malignant pleural mesothelioma. (2005) (108)
Prospective trial of preoperative concomitant boost radiotherapy with continuous infusion 5-fluorouracil for locally advanced rectal cancer. (2000) (108)
FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer (2016) (107)
Drug approval summaries: arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene. (2001) (105)
U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis (2012) (105)
Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015. (2017) (102)
Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. (2010) (101)
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab (2017) (100)
Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) (2012) (99)
FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia (2015) (98)
FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer. (2005) (98)
Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase. (2003) (96)
FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma. (2010) (94)
Developing drugs to decrease the toxicity of chemotherapy. (2001) (93)
Seamless Oncology-Drug Development. (2016) (91)
Accelerated approval of oncology products: a decade of experience. (2004) (91)
Phase I study with pharmacokinetics of S-1 on an oral daily schedule for 28 days in patients with solid tumors. (2003) (90)
U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab (2010) (90)
FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden–High Solid Tumors (2021) (90)
U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens (2008) (89)
First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer (2013) (89)
Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis. (2018) (88)
FDA Approval: Siltuximab for the Treatment of Patients with Multicentric Castleman Disease (2015) (88)
FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib (2016) (84)
FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia (2019) (84)
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non–Small Cell Lung Cancer (2017) (84)
FDA drug approval summary: alemtuzumab as single-agent treatment for B-cell chronic lymphocytic leukemia. (2008) (82)
Thymidylate synthase inhibitors. (1996) (81)
Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1-defined disease progression in clinical trials. (2017) (81)
Real‐world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non–small cell lung cancer (2019) (80)
Randomized, open-label, phase III study of a 28-day oral regimen of eniluracil plus fluorouracil versus intravenous fluorouracil plus leucovorin as first-line therapy in patients with metastatic/advanced colorectal cancer. (2002) (80)
Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer. (2002) (78)
The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology. (2010) (77)
Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval. (2018) (77)
FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy (2018) (76)
FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease (2018) (76)
Pharmacokinetics and toxicity of continuous infusion amphotericin B in cancer patients. (1989) (75)
FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration. (2017) (74)
FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma (2017) (74)
Approval Summary: Nelarabine for the Treatment of T-Cell Lymphoblastic Leukemia/Lymphoma (2006) (74)
FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma. (2008) (74)
FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1 (2020) (73)
Low serum alpha‐fetoprotein level in patients with hepatocellular carcinoma as a predictor of response to 5‐fu and interferon‐alpha‐2b (1993) (73)
Prospective evaluation of adrenal insufficiency in patients with adrenal metastasis (1987) (73)
FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation (2019) (72)
Reevaluating Eligibility Criteria - Balancing Patient Protection and Participation in Oncology Trials. (2017) (72)
Low‐dose continuous infusion 5‐fluorouracil. Evaluation in advanced breast carcinoma (1989) (71)
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma (2017) (70)
Optimizing Dosing of Oncology Drugs (2014) (69)
U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia. (2014) (69)
Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas. (2007) (68)
FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma (2020) (68)
Approval Summary (2004) (68)
Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer (2016) (67)
FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis (2017) (67)
Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC). (2010) (67)
Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop. (2007) (66)
UFT and leucovorin: a review of its clinical development and therapeutic potential in the oral treatment of cancer. (1998) (66)
FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer (2018) (66)
Dexrazoxane (Totect): FDA review and approval for the treatment of accidental extravasation following intravenous anthracycline chemotherapy. (2008) (66)
Approval summary: pemetrexed in the initial treatment of advanced/metastatic non-small cell lung cancer. (2009) (65)
Ixabepilone in Combination with Capecitabine and as Monotherapy for Treatment of Advanced Breast Cancer Refractory to Previous Chemotherapies (2008) (63)
Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma. (2007) (63)
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma (2017) (62)
FDA Approval Summary: Olaparib monotherapy or in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer. (2020) (62)
Neuroendocrine carcinoma of the cervix: implications for staging and therapy. (1981) (62)
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non–Small Cell Lung Cancer Trials: A Meta-analysis (2017) (61)
Response rates, survival, and chemotherapy trials. (2000) (61)
Phase II study of capecitabine in patients with fluorouracil-resistant metastatic colorectal carcinoma. (2004) (61)
FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies. (2018) (61)
FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer (2019) (61)
Successes and Challenges of PARP Inhibitors in Cancer Therapy (2015) (60)
Elevated plasma thrombopoietic activity in patients with metastatic cancer-related thrombocytosis. (1995) (60)
'Tomudex' (ZD1694): a novel thymidylate synthase inhibitor with clinical antitumour activity in a range of solid tumours. 'Tomudex' International Study Group. (1996) (60)
FDA Approval Summary: Ramucirumab for Gastric Cancer (2015) (60)
Phase I study of preoperative oral uracil and tegafur plus leucovorin and radiation therapy in rectal cancer. (2000) (60)
Controlled clinical trial of interferon-gamma as postoperative surgical adjuvant therapy for colon cancer. (1995) (59)
U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma. (2012) (59)
FDA drug approval summaries: fulvestrant. (2002) (59)
Phase II Study of Dolastatin-10 as First-Line Treatment for Advanced Colorectal Cancer (2002) (59)
Phase I trials of uracil‐tegafur (UFT) using 5 and 28 day administration schedules: demonstration of schedule‐dependent toxicities (1996) (58)
US Food and Drug Administration approval overview in metastatic breast cancer. (2012) (58)
U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid. (2002) (57)
Analysis of early mortality in randomized clinical trials evaluating anti-PD-1/PD-L1 antibodies: A systematic analysis by the United States Food and Drug Administration (FDA). (2019) (56)
Metastasis-free Survival - A New End Point in Prostate Cancer Trials. (2018) (56)
Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval. (2018) (54)
Approval summary: pemetrexed maintenance therapy of advanced/metastatic nonsquamous, non-small cell lung cancer (NSCLC). (2010) (54)
The role of nonrandomized trials in the evaluation of oncology drugs (2015) (54)
Patient-reported outcomes supporting anticancer product approvals. (2007) (53)
FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy (2017) (53)
Rare Cancer Trial Design: Lessons from FDA Approvals (2012) (53)
Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration. (2016) (53)
Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: U.S. Food and Drug Administration Drug Approval Summary (2013) (52)
Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors. (2010) (51)
FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer (2015) (51)
FDA subset analysis of the safety of nivolumab in elderly patients with advanced cancers. (2016) (51)
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer (2016) (50)
The Drug-Dosing Conundrum in Oncology - When Less Is More. (2021) (49)
FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs (2016) (49)
FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease. (2019) (49)
Folotyn (Pralatrexate Injection) for the Treatment of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma: U.S. Food and Drug Administration Drug Approval Summary (2010) (49)
Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies (2017) (49)
FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (2019) (48)
FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation (2017) (48)
FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen (2017) (48)
Colonic small cell undifferentiated carcinoma: a distinct pathological diagnosis with therapeutic implications. (1987) (48)
FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer. (2009) (48)
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma (2020) (47)
Cisplatin and 5-fluorouracil as salvage therapy for recurrent metastatic squamous cell carcinoma of the anal canal. (1993) (47)
Phase II evaluation of fluorouracil and recombinant α‐2a‐interferon in previously untreated patients with pancreatic adenocarcinoma (1992) (46)
Effect of initial resection of small-cell carcinoma of the lung: a review of Southwest Oncology Group Study 7628. (1985) (46)
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions (2020) (45)
Fulvestrant in postmenopausal women with advanced breast cancer. (2003) (45)
Next-Generation Sequencing in Oncology in the Era of Precision Medicine. (2016) (44)
FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer (2018) (44)
A phase III trial comparing oral UFT to FULV in stage II and III carcinoma of the colon: Results of NSABP Protocol C-06 (2004) (44)
Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer (2008) (44)
Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections (2017) (43)
Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary (2013) (43)
FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis (2020) (43)
Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer. (2013) (43)
FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer (2020) (43)
FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma (2021) (43)
Phase II trial of 9-aminocamptothecin administered as a 72-hour continuous infusion in metastatic colorectal carcinoma. (1997) (42)
Abstract S1-11: Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) (2012) (42)
U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer (2018) (42)
Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis (2020) (42)
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma (2017) (42)
Phase II trial of docetaxel (Taxotere) in metastatic colorectal carcinoma. (1994) (42)
Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis (2020) (42)
The oral fluorouracil prodrugs. (1998) (42)
Phase I trial of uracil-tegafur (UFT) plus oral leucovorin: 28-day schedule. (1998) (41)
Immunotherapy Combinations in Multiple Myeloma - Known Unknowns. (2018) (41)
Assessing Tumor-Related Signs and Symptoms to Support Cancer Drug Approval (2004) (41)
FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC. (2021) (40)
Enrollment of older adults on oncology trials: An FDA perspective. (2017) (40)
Low‐Dose Continuous Infusion 5‐Fluorouracil and Cisplatin: Phase II Evaluation in Advanced Colorectal Carcinoma (1989) (40)
Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a “Physician's Choice” Control Arm in a Randomized Approval Trial (2012) (39)
A Review of its Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Efficacy in the Management of Metastatic Breast Cancer (1996) (39)
Intensive preoperative chemotherapy with colony-stimulating factor for resectable adenocarcinoma of the esophagus or gastroesophageal junction. (1993) (38)
Approval Summary: Docetaxel in Combination with Prednisone for the Treatment of Androgen-Independent Hormone-Refractory Prostate Cancer (2004) (38)
FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation (2018) (38)
Colorectal Cancer: Diagnosis and Management (2005) (38)
FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer. (2021) (38)
Neurotoxicity of CI-980, a novel mitotic inhibitor. (1997) (37)
Phase II trial of docetaxel for cholangiocarcinoma. (1999) (37)
FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors (2020) (37)
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer (2020) (37)
Letrozole in the Extended Adjuvant Treatment of Postmenopausal Women with History of Early-Stage Breast Cancer Who Have Completed 5 Years of Adjuvant Tamoxifen (2005) (36)
FDA Approval Summary: Brentuximab Vedotin in First‐Line Treatment of Peripheral T‐Cell Lymphoma (2019) (35)
Oncology drug development: United States Food and Drug Administration perspective. (2002) (35)
U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma (2016) (35)
Topotecan in combination with cisplatin for the treatment of stage IVB, recurrent, or persistent cervical cancer. (2006) (35)
FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma (2018) (34)
Gleevec for the treatment of chronic myelogenous leukemia: US. Food and Drug Administration regulatory mechanisms, accelerated approval, and orphan drug status. (2002) (34)
U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia (2014) (34)
Under‐representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993‐2013 (2014) (33)
Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis. (2019) (33)
Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer. (2019) (33)
FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper. (2017) (33)
FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B‐Cell Acute Lymphoblastic Leukemia (2018) (32)
Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy. (2017) (32)
"Dangling" Accelerated Approvals in Oncology. (2021) (32)
Fluoropyrimidines: A Critical Evaluation (1999) (32)
Phase I and pharmacokinetic study of exatecan mesylate (DX-8951f): a novel camptothecin analog. (2001) (32)
Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle (2016) (31)
Regulatory watch: From big data to smart data: FDA's INFORMED initiative (2017) (31)
External Control Arms in Oncology: Current Use and Future Directions (2022) (31)
Challenges to use of health-related quality of life for Food and Drug Administration approval of anticancer products. (2007) (30)
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutated -Metastatic Castrate Resistant Prostate Cancer. (2020) (30)
Metoclopramide versus metoclopramide and lorazepam. Superiority of combined therapy in the control of cisplatin‐induced emesis (1989) (30)
U.S. Food and drug administration approval: rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia. (2011) (30)
FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome (2019) (30)
FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions (2021) (30)
FDA Approval Summary: Nivolumab plus ipilimumab for the treatment of patients with hepatocellular carcinoma previously treated with sorafenib. (2021) (30)
Effect of food on the oral bioavailability of UFT and leucovorin in cancer patients. (2001) (30)
FDA Approval Summary: TAS-102 (2017) (29)
Comparison of etoposide and cisplatin with bis‐chloro‐ethylnitrosourea, thiotepa, vincristine, and cyclophosphamide for salvage treatment in small cell lung cancer. A Southwest Oncology Group Study (1990) (29)
Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health (2021) (29)
Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy: A Pooled Analysis of Trials in the US Food and Drug Administration Database. (2022) (29)
FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis (2018) (29)
An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies (2016) (29)
Metastatic sweat gland carcinoma: Response to 5‐fluorouracil infusion (1989) (28)
FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer (2020) (27)
FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen (2017) (27)
FDG-PET lymphoma demonstration project invitational workshop. (2007) (27)
Phase II trial of ZD1694 (TomudexTM) in patients with advanced pancreatic cancer (1995) (27)
Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice. (2021) (27)
FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations (2021) (27)
Treatment Beyond Progression With Immune Checkpoint Inhibitors-Known Unknowns. (2017) (26)
Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. (2008) (26)
Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis. (2021) (26)
U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer. (2015) (26)
Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials (2013) (26)
FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease. (2020) (26)
Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials (2015) (26)
Response Rate as an Approval End Point in Oncology: Back to the Future. (2016) (25)
Cardiovascular adverse events in immune checkpoint inhibitor clinical trials: A U.S. Food and Drug Administration pooled analysis. (2018) (25)
Consensus Report of a Joint NCI Thoracic Malignancies Steering Committee: FDA Workshop on Strategies for Integrating Biomarkers into Clinical Development of New Therapies for Lung Cancer Leading to the Inception of “Master Protocols” in Lung Cancer (2014) (25)
FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer (2021) (25)
Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer. (2019) (25)
Deferasirox for the treatment of chronic iron overload in transfusional hemosiderosis. (2006) (25)
U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy. (2015) (25)
Oral uracil and Ftorafur plus leucovorin: pharmacokinetics and toxicity in patients with metastatic cancer (2000) (25)
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response (2016) (25)
The FDA Oncology Center of Excellence and precision medicine (2018) (24)
Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective (2014) (24)
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer (2020) (24)
The Wild West of Checkpoint Inhibitor Development. (2021) (24)
FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation (2021) (24)
FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer (2020) (24)
Outcomes of anti-PD-(L1) therapy in combination with chemotherapy versus immunotherapy (IO) alone for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 score 1-49%: FDA pooled analysis. (2021) (24)
Medical oncology : a comprehensive review (1993) (24)
Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura. (2009) (23)
Incidence of Differentiation Syndrome with Ivosidenib (IVO) and Enasidenib (ENA) for Treatment of Patients with Relapsed or Refractory (R/R) Isocitrate Dehydrogenase (IDH)1- or IDH2-Mutated Acute Myeloid Leukemia (AML): A Systematic Analysis By the U.S. Food and Drug Administration (FDA) (2018) (23)
Residual Disease after Neoadjuvant Therapy - Developing Drugs for High-Risk Early Breast Cancer. (2019) (23)
Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016. (2018) (23)
Phase II study of gemcitabine in advanced colorectal adenocarcinoma (1992) (23)
Phase I trial of Uracil-Tegafur (UFT) plus oral leucovorin: 14-day schedule (2004) (23)
Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy. (2019) (23)
Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review (2019) (22)
Phase II study of UFT plus leucovorin in colorectal cancer. (1997) (22)
FDA's Approach to Regulating Biosimilars (2016) (22)
Phase I and pharmacokinetic evaluations of UFT plus oral leucovorin. (1997) (22)
Phase II evaluation of iproplatin in patients with advanced gastric and pancreatic cancer. (1992) (21)
Project Orbis: Global Collaborative Review Program (2020) (21)
A phase II trial of recombinant human interferon-gamma and recombinant tumor necrosis factor in patients with advanced gastrointestinal malignancies: results of a trial terminated by excessive toxicity. (1990) (21)
Pilot phase II trial of 13-cis-retinoic acid and interferon-alpha combination therapy for advanced pancreatic adenocarcinoma. (1995) (21)
Phase II trial of ZD1694 (Tomudex) in patients with advanced pancreatic cancer. (1996) (20)
A Phase II trial of 5‐fluorouracil and recombinant alpha‐2a‐interferon in previously untreated metastatic gastric carcinoma (1992) (20)
FDA's Approval of the First Biosimilar to Bevacizumab (2018) (20)
FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma. (2020) (20)
Development of effective new treatments for multiple myeloma. (2005) (20)
Clinical pharmacology of combined oral uracil and ftorafur. (1992) (20)
FDA analysis of depth of response (DpR) and survival across 10 randomized controlled trials in patients with previously untreated unresectable or metastatic melanoma (UMM) by therapy type. (2019) (20)
The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint. (2022) (19)
FDA Approval Summary: Selumetinib for Plexiform Neurofibroma (2021) (19)
FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults (2019) (19)
FDA analysis of pembrolizumab trials in multiple myeloma: Immune related adverse events (irAEs) and response. (2018) (18)
FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review (2021) (18)
Phase I assessment of the pharmacokinetics, metabolism, and safety of emitefur in patients with refractory solid tumors. (2000) (18)
Phase II evaluation of recombinant alpha‐2a‐interferon and continuous infusion fluorouracil in previously untreated metastatic colorectal adenocarcinoma (1993) (18)
FDA analysis of patients with baseline autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents. (2017) (18)
FDA Analysis of Racial Demographics in Multiple Myeloma Trials (2017) (18)
The advisory process for anticancer drug regulation: a global perspective. (2006) (17)
Eltrombopag for the treatment of chronic immune (idiopathic) thrombocytopenic purpura. (2009) (17)
FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer (2020) (17)
Colorectal cancer: chemotherapy treatment overview. (2000) (17)
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review (2021) (17)
A phase III trial comparing oral UFT to FULV in stage II and III carcinoma of the colon: Results of NSABP Protocol C-06. (2004) (17)
Approvals in 2016: the march of the checkpoint inhibitors (2017) (17)
Pediatric hepatic tumors: Clinical trials conducted in the United States (1993) (17)
Approval summary: imatinib mesylate for one or three years in the adjuvant treatment of gastrointestinal stromal tumors. (2012) (17)
Phase I trial of sulindac plus 5-fluorouracil and levamisole: potential adjuvant therapy for colon carcinoma. (1996) (17)
Adjuvant medical therapy for colorectal cancer. (1997) (17)
Phase I study of irinotecan and concurrent radiation therapy for upper GI tumors. (2000) (17)
Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer (2015) (17)
Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration. (2020) (16)
Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience (2017) (16)
FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer (2022) (16)
Progress in the development of novel treatments for colorectal cancer. (2004) (16)
The value meal: effect of food on lapatinib bioavailability. (2007) (16)
Pediatric oncology: regulatory initiatives. (2000) (16)
FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma (2017) (16)
Survival of ethnic and racial minority patients with multiple myeloma treated with newer medications. (2018) (15)
FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma (2021) (15)
Overall response rate (ORR) as a potential surrogate for progression-free survival (PFS): A meta-analysis of metastatic non-small cell lung cancer (mNSCLC) trials submitted to the U.S. Food and Drug Administration (FDA). (2014) (15)
A phase II trial of paclitaxel (Taxol) in advanced esophageal cancer: preliminary report. (1994) (15)
FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma. (2020) (15)
Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib (2018) (14)
Phase II trial of intravenous CI-980 (NSC 370147) in patients with metastatic colorectal carcinoma. Model for prospective evaluation of neurotoxicity. (1997) (14)
Fludarabine Phosphate Phase II Evaluation in Advanced Soft‐Tissue Sarcomas (1987) (14)
An FDA Pooled Analysis of Patients with Melanoma Treated with an Anti-PD1 Antibody Beyond RECIST Progression (2018) (14)
Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science (2017) (14)
FDA Approval Summary: Belzutifan for von Hippel-Lindau disease associated tumors. (2022) (14)
FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as single agents for first-line treatment of advanced/metastatic PD-L1 high NSCLC. (2022) (14)
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. (2018) (14)
A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Multiple Myeloma (2018) (14)
Systemic therapies for unresectable primary hepatic tumors (1993) (14)
Phase I trial of spiromustine (NSC 172112) and evaluation of toxicity and schedule in a murine model. (1987) (14)
Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy (2017) (14)
Abstract GS5-06: A U.S. food and drug administration pooled analysis of outcomes of older women with hormone-receptor positive metastatic breast cancer treated with a CDK4/6 inhibitor as initial endocrine based therapy (2018) (14)
Association of baseline body mass index (BMI) with overall survival (OS) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) treated with nivolumab (N) and pembrolizumab (P). (2018) (14)
A strategic framework for novel drug development in multiple myeloma (2007) (14)
Accelerated approval and oncology drug development timelines. (2010) (14)
Assessment of Audit Methodologies for Bias Evaluation of Tumor Progression in Oncology Clinical Trials (2013) (14)
INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology (2018) (13)
Approvals in 2017: gene therapies and site-agnostic indications (2018) (13)
Irinotecan: toward clinical end points in drug development. (1998) (13)
FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma (2021) (13)
The impact of the written request process on drug development in childhood cancer (2013) (13)
Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses (2021) (13)
Modulation of fluorouracil with recombinant alfa interferon: M. D. Anderson Clinical trial. (1992) (13)
An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer (2020) (13)
Minimal Residual Disease as a Potential Surrogate End Point-Lingering Questions. (2017) (13)
Phase II trial of 9-aminocamptothecin (NSC 603071) administered as a 120-hour continuous infusion weekly for three weeks in metastatic colorectal carcinoma (1998) (13)
Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma. (1994) (13)
A Phase II Study of Intravenous Exatecan Mesylate (DX-8951f) Administered Daily for Five Days Every Three Weeks to Patients with Metastatic Adenocarcinoma of the Colon or Rectum (2004) (13)
Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation. (2020) (12)
Metastatic breast cancer (MBC): FDA approval overview (2008) (12)
Dihydropyrimidine dehydrogenase inhibitory fluoropyrimidines: a novel class of oral antineoplastic agents. (1999) (12)
Outcomes of anti–PD-(L)1 therapy with or without chemotherapy (chemo) for first-line (1L) treatment of advanced non–small cell lung cancer (NSCLC) with PD-L1 score ≥ 50%: FDA pooled analysis. (2022) (12)
FDA Approval Summary: Margetuximab plus chemotherapy for advanced or metastatic HER2-positive breast cancer. (2021) (11)
Phase I study of echinomycin. (1987) (11)
U.S. FDA Drug Approvals for Breast Cancer - A Decade in Review. (2021) (11)
A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Non‐Small Cell Lung Cancer (2016) (11)
Characterization of patients treated with a programmed cell death protein 1 inhibitor (anti-PD-1) past RECIST progression from a metastatic non-small cell lung cancer (mNSCLC) trial. (2016) (11)
Promoting Inclusion of Members of Racial and Ethnic Minority Groups in Cancer Drug Development. (2021) (10)
Phase II study of ZD1694 in patients with advanced gastric cancer. (1996) (10)
CBDCA: Phase II Evaluation in Advanced Colorectal Carcinoma (1987) (10)
Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study (2016) (10)
Importing oncology trials from China: a bridge over troubled waters? (2022) (10)
U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program (2020) (10)
Phase II trial of 9-aminocamptothecin (NSC 603071) administered as a 120-hr continuous infusion weekly for three weeks in metastatic colorectal carcinoma. (1998) (10)
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion (2021) (10)
U.S. Food and Drug Administration approval summary: Eltrombopag for the treatment of pediatric patients with chronic immune (idiopathic) thrombocytopenia (2017) (10)
Relationship between OS and PFS in metastatic breast cancer (MBC): Review of FDA submission data. (2011) (10)
Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective. (2021) (10)
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (2003) (10)
An FDA Analysis of Survival Outcomes Comparing an Adjuvant Paclitaxel and Trastuzumab Trial to an External Control from Historical Clinical Trials. (2020) (9)
FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (2022) (9)
Benefit of CDK 4/6 inhibition in less common breast cancer subsets: A U.S. Food and Drug Administration pooled analysis. (2018) (9)
Fluorouracil and recombinant interferon alfa‐2a in advanced gastrointestinal neoplasms (1991) (9)
Neuroendocrine small cell carcinomas in miscellaneous primary sites: implications for staging and therapy. (1981) (9)
Tegafur/uracil + calcium folinate in colorectal cancer: double modulation of fluorouracil. (1999) (9)
FDA analysis of treatment beyond disease progression disease (PD) in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab vs. everolimus. (2016) (9)
Tegafur/Uracil + Calcium Folinate in Colorectal Cancer (2012) (9)
The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment. (2018) (9)
Regulatory watch: Why do oncology drugs fail to gain US regulatory approval? (2015) (9)
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy (2020) (9)
Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer. (2019) (9)
FDA Approval Summary: Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (2021) (9)
Outcomes of first-line immune checkpoint inhibitors with or without chemotherapy according to KRAS mutational status and PD-L1 expression in patients with advanced NSCLC: FDA pooled analysis. (2022) (9)
Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: FDA Oncology Center of Excellence Public Workshop. (2019) (8)
Phase II study of amonafide in advanced pancreatic adenocarcinoma (1991) (8)
The On- and Off-Ramps of Oncology Accelerated Approval. (2022) (8)
Phase II trial of edatrexate in patients with advanced hepatocellular carcinoma. (1994) (8)
Linitis plastica of the esophagus. (1988) (8)
Clinical trials of fluorouracil with alpha-interferon in advanced colorectal carcinomas. (1991) (8)
Nonclinical Evaluations of Small-Molecule Oncology Drugs: Integration into Clinical Dose Optimization and Toxicity Management (2016) (8)
Novel oral chemotherapy agents (2000) (8)
Sequential biochemical modulation of fluorouracil with folinic acid, N-phosphonacetyl-L-aspartic acid, and interferon alfa-2a in advanced colorectal cancer. (1999) (8)
Phase I Study of 5‐Fluorouracil with Folinic Acid Combined with Recombinant Human Granulocyte‐Macrophage Colony‐Stimulating Factor (1992) (8)
Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval. (2011) (8)
US Food and Drug Administration Efforts to Facilitate the Use of Expanded Access Programs. (2015) (7)
Conflicting phase II efficacy data for Doxil. (2001) (7)
Second Cancers in Adults with Acute Promyelocytic Leukemia (APL) Treated with or without Arsenic Trioxide (ATO): A SEER-Medicare Analysis (2019) (7)
Phase I bioequivalency study of MitoExtra and mitomycin C in patients with solid tumors (2001) (7)
Phase II Study of MGI‐114 Administered Intravenously for 5 Days Every 28 Days to Patients With Metastatic Colorectal Cancer (2003) (7)
An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs. (2016) (7)
FDA Approval Summary: Ivosidenib for the treatment of patients with advanced unresectable or metastatic, chemotherapy refractory cholangiocarcinoma with an IDH1 mutation. (2022) (7)
Phase I trial of intoplicine (RP 60475) administered as a 72 h infusion every 3 weeks in patients with solid tumors. (1999) (7)
Oncology clinical trials (2013) (7)
Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials. (2021) (7)
Pharmacokinetics of recombinant human interferon-alpha 2a combined with 5-fluorouracil in patients with advanced colorectal carcinoma. (1998) (7)
Cytotoxic chemotherapy for cancer in Felty's syndrome: role of lithium carbonate. (1981) (7)
Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion (2021) (7)
Oral fluoropoyrimidines. (1999) (7)
Progress in Colorectal Cancer Chemotherapy (2000) (7)
Approvals in 2019: international review and a new agnostic molecular entity (2020) (7)
Preoperative combined oral UFT plus leucovorin and radiation therapy for rectal cancer. (1997) (6)
Asian representation in clinical trials of new drugs for the treatment of cancer. (2017) (6)
Second cancers in adults with acute promyelocytic leukemia treated with or without arsenic trioxide: a SEER-medicare analysis (2020) (6)
FDA approval summary: decitabine and cedazuridine tablets for myelodysplastic syndromes. (2022) (6)
Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials (2022) (6)
Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition (2022) (6)
FDA evaluation of hepatotoxicity related to tyrosine kinase inhibitors. (2011) (6)
Phase I trial of FK973: Description of a delayed vascular leak syndrome (1991) (6)
Contribution of Early Clinical Benefit End Points to Decreased Lung Cancer Mortality Rates. (2021) (6)
Evaluation of the correlation between antibiotic use and survival in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) treated with immune checkpoint inhibitors (ICIs). (2020) (6)
Accelerated Approval Is Not Conditional Approval: Insights From International Expedited Approval Programs. (2022) (6)
Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs. (2017) (6)
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma (2019) (6)
Phase II trial of fazarabine in advanced colorectal carcinoma (1992) (6)
Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop (2021) (6)
Hepatic arterial embolization for treatment of glucagonomas: antineoplastic and palliative benefits. (1990) (6)
Novel chemotherapeutic agents for gastrointestinal cancers. (1999) (6)
FDA analysis of outcomes in Asian patients (pts) with metastatic non-small cell lung cancer (mNSCLC) receiving immune checkpoint inhibitors (ICI). (2019) (6)
Racial composition in trials supporting the U.S. approval of anti-cancer new molecular entities (NMEs): 2011- 2016. (2017) (6)
Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer. (2019) (6)
Regulatory considerations on endpoints in ovarian cancer drug development (2017) (5)
Clinician Perspectives on Current Issues in Lung Cancer Drug Development (2016) (5)
Enrollment of Hispanics in cancer clinical trials: An FDA analysis. (2018) (5)
Fibrolamellar hepatocellular carcinoma. Therapeutic implications of a ten-year disease-free interval. (1991) (5)
Oncology approvals in 2020: a year of firsts in the midst of a pandemic (2021) (5)
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples (2021) (5)
Toxicity of laromustine plus high-dose cytarabine in patients with relapsed acute myeloid leukemia. (2010) (5)
Report from the FDA Approval Summary: Imatinib Mesylate Capsules for Treatment of Adult Patients with Newly Diagnosed Philadelphia Chromosome- positive Chronic Myelogenous Leukemia in Chronic Phase (2003) (5)
Global Variation in Opioid Use in Prostate Cancer Trials. (2019) (5)
Rates of PD-L1 expression testing in U.S. community-based oncology practices (USCPs) for patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab (N) or pembrolizumab (P). (2017) (5)
The FDA's new oncology office. (2005) (5)
Aclacinomycin A Phase II Evaluation in Advanced Soft Tissue Sarcoma (1987) (5)
Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA (2016) (5)
Gemtuzumab ozogamicin (2013) (5)
The Phase III Clinical Cancer Trial (2004) (5)
US Food and Drug Administration regulatory updates in neuro-oncology (2021) (5)
FDA Oncology Center of Excellence During COVID-19-Working for Patients With Cancer. (2020) (5)
Oxaliplatin and UFT/oral calcium folinate for advanced colorectal carcinoma. (1999) (5)
Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective. (2017) (5)
FDA Approval Summary: lutetium Lu 177 vipivotide tetraxetan for patients with metastatic castration-resistant prostate cancer. (2022) (5)
Accelerated approvals hit the target in precision oncology (2022) (5)
Leveraging the Success of HIV Drug Development Paradigms for Cancer (2018) (4)
Exploratory responder analyses of greatest depth of response (DepOR) and survival in patients with metastatic non-small cell lung cancer (mNSCLC) treated with a targeted therapy or immunotherapy. (2016) (4)
US Food and Drug Administration Support for Oncology Drug Development During COVID-19. (2020) (4)
Trastuzumab cardiotoxicity: FDA review of four adjuvant breast cancer clinical trials leading to trastuzumab marketing approvals. (2009) (4)
FDA analysis of patient enrollment by region in clinical trials for approved oncological indications. (2017) (4)
Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies (2020) (4)
Clinical Status and Future Directions of Irinotecan (1998) (4)
REGULATORY CONSIDERATIONS IN CLINICAL TRIALS OF NOVEL ANTICANCER DRUGS (2006) (4)
FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer. (2022) (4)
Regulatory considerations for early clinical studies of anti-cancer drugs in healthy volunteers (2005) (4)
Phase I trial of i.v. administered tirapazamine plus cyclophosphamide (2001) (4)
Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma (2017) (4)
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs (2020) (4)
An FDA analysis of the association of tumor growth rate and overall and progression-free survival in metastatic non-small cell lung cancer (NSCLC) patients. (2020) (4)
Evaluating Cancer Drugs in Patients With Central Nervous System Metastases. (2021) (4)
Phase I study and pharmacokinetics of caracemide (NSC-253272) administered as a short infusion (1987) (4)
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma (2020) (4)
Association of clinical benefit rate (CBR) with survival: A pooled-analysis of metastatic breast cancer (MBC) trials submitted to the U.S. Food and Drug Administration (FDA). (2016) (4)
FDA breakthrough therapy designation for oncology products: The CBER experience. (2018) (4)
FDA analysis of MRD data in hematologic malignancy applications. (2017) (4)
Medical Management of Colorectal Carcinomas (1994) (4)
FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. (2022) (4)
Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy. (2020) (4)
Exploration of baseline derived neutrophil to lymphocyte ratio (dNLR) and lactate dehydrogenase (LDH) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) treated with immune checkpoint inhibitors (ICI) or cytotoxic chemotherapy (CCT). (2018) (3)
Phase II trial of 5-fluorouracil, folinic acid and recombinant alpha-2a-interferon in patients with advanced colorectal cancer. (1999) (3)
Phase II study of prolonged infusion of Taxol in patients with metastatic colorectal carcinoma (2004) (3)
Looking to the future in an unprecedented time for cancer drug development. (2016) (3)
Impact of antibiotic use on clinical outcomes in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody. (2019) (3)
Multiple primary malignancies. (1984) (3)
Phase II study of intravenous 6-thioguanine in patients with advanced carcinoma of the pancreas (1991) (3)
FDA Approval of Prostate Cancer Treatments (2010) (3)
A phase I study. Preoperative UFT/leucovorin and radiation therapy in rectal cancer. (2000) (3)
Use of progression-free survival (PFS) as an endpoint in advanced non-small cell lung cancer (NSCLC) trials: FDA perspective. (2010) (3)
U.S. FDA Drug Approvals for Gynecological Malignancies - A Decade in Review. (2021) (3)
Response Rate, Event-Free Survival (EFS), and Overall Survival (OS) in Newly-Diagnosed Acute Myeloid Leukemia (AML): U.S. Food and Drug Administration (FDA) Trial-Level and Patient-Level Analyses (2018) (3)
Report : Eculizumab ( Soliris ) for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria (2008) (3)
Phase I trial of combined irinotecan and oxaliplatin given every three weeks to patients with metastatic colorectal cancer (2004) (3)
Phase II Study of Intravenous CI-958 in Metastatic Colorectal Adenocarcinoma (2000) (3)
FDA analysis: Impact of BMI on efficacy outcomes in multiple myeloma trials. (2020) (3)
Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients. (2022) (3)
Phase II trial of piroxantrone in metastatic gastric adenocarcinoma (2004) (3)
Report from the Food and Drug Administration Pemetrexed in Malignant Pleural Mesothelioma (2005) (3)
Adjuvant breast cancer: FDA approval overview. (2009) (3)
FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners. (2020) (3)
Project Switch: Docetaxel as a potential synthetic control in metastatic non-small cell lung cancer (mNSCLC) trials. (2019) (3)
Phase II evaluation of aclacinomycin‐A in patients with adenocarcinoma and large cell carcinoma of the lung (1985) (3)
FDA Approval Summary: Sonidegib—Response (2017) (3)
Adjuvant therapy for colon carcinoma. (1989) (3)
FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GVHD After Two or More Prior Lines of Systemic Therapy. (2022) (3)
Phase II trial of mitomycin, vindesine, and hexamethylmelamine in metastatic non-small cell bronchogenic carcinoma. (1986) (3)
Project facilitate: A review of the FDA oncology center of excellence expanded access pilot program. (2020) (3)
Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs. (2020) (3)
Impact of radiotherapy on risk of adverse events in patients receiving immunotherapy: A U.S. Food and Drug Administration pooled analysis. (2020) (3)
An FDA-pooled analysis of frontline combination treatment benefits by risk groups in metastatic renal cell carcinoma (mRCC). (2021) (2)
Project Switch: Lenalidomide and dexamethasone (Len-Dex) as a potential synthetic control arm (SCA) in relapsed or refractory multiple myeloma (rrMM). (2019) (2)
FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial. (2022) (2)
Accelerated vs. regular approval: Lessons learned from U.S. FDA oncology approvals. (2018) (2)
The seamless approach to drug development in oncology. (2016) (2)
Expanded access program (EAP) to investigational drugs. (2004) (2)
Acodazole hydrochloride: phase I trial, pharmacokinetics, and evaluation of cardiotoxicity in dogs. (1988) (2)
Preoperative UFT/ leucovorin and radiation therapy in rectal cancer (2000) (2)
Demographic composition of lung cancer trials: FDA analysis. (2018) (2)
Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs. (2019) (2)
Enrollment of racial/ethnic minority patients in ovarian and breast cancer trials: An FDA analysis. (2018) (2)
FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients (2020) (2)
Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021. (2022) (2)
5-Fluorouracil and recombinant interferon alfa-2a: review of activity and toxicity in advanced colorectal carcinomas. (1991) (2)
Regulatory implications of ctDNA in immuno-oncology for solid tumors (2023) (2)
UFT: East meets West in drug development. (1997) (2)
U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Na¨ ı ve Metastatic Castration-Resistant Prostate Cancer (2015) (2)
Impact of timing of antibiotic use on clinical outcomes in patients with urothelial cancer treated with immune checkpoint inhibitors (ICIs). (2020) (2)
Outcomes in patients with advanced non-small cell lung cancer (aNSCLC) and high PD-L1 expression treated with immune checkpoint inhibitor monotherapy: An FDA-pooled analysis. (2020) (2)
[Medical treatment of colorectal cancer]. (1996) (2)
Use of single-arm trials to support malignant hematology and oncology drug and biologic approvals: A 20-year FDA experience. (2021) (2)
Report from the FDA Approval Summary for Zoledronic Acid for Treatment of Multiple Myeloma and Cancer Bone Metastases (2003) (2)
An Analysis of Recent FDA Oncology Scientific Publications. (2019) (2)
Aclacinomycin A Phase II Evaluation in Bronchogenic Squamous‐Cell Carcinoma (1987) (2)
Association of progression-free survival and overall response rate with overall survival in first-line randomized trials of immune checkpoint inhibitor–based regimens for metastatic non–small cell lung cancer (NSCLC): An FDA pooled analysis. (2022) (2)
The Role of FDA in the Regulation of Anti-Cancer Drugs (2006) (2)
Preoperative UFT and calcium folinate and radiotherapy in rectal cancer. (1999) (2)
Phase II study of intravenous 6-thioguanine in patients with advanced gastric carcinoma (1991) (2)
An FDA pooled analysis: Characteristics and outcomes of patients with nonmetastatic castration-resistant prostate cancer, based on prior history of prostatectomy and/or radiation therapy. (2021) (2)
FDA analysis of ECOG performance status and safety outcomes. (2020) (1)
Abstract P5-14-02: Time to treatment discontinuation as a pragmatic endpoint: A U.S. Food and Drug Administration pooled analysis of CDK 4/6 inhibitors (2019) (1)
Clinical Trial Design and Regulatory Issues (2007) (1)
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINSTRATION ODS POSTMARKETING SAFETY REVIEW TO : (2005) (1)
Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia. (2021) (1)
Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development. (2022) (1)
Registration by the European Agency for the Evaluation of Medicinal products (EMEA) of oncology products approved by the Food and Drug Administration (FDA) under accelerated approval (AA) regulations (2005) (1)
PROs: defining clinical benefit from the patient's perspective. Draft guidance provides direction in evaluating patient-reported outcomes. (2006) (1)
Phase Ii trial of 5-fluorouracil, folinic acid and recombinant α-2a-interferon in patients with advanced colorectal cancer (1999) (1)
Timing of assessments for PRO measures in advanced RCC clinical trials. (2020) (1)
An FDA analysis of the association between adverse events and outcome in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody. (2019) (1)
Development of Tissue-Agnostic Treatments for Patients with Cancer (2022) (1)
Report from the FDA Approval Summary: Letrozole in the Treatment of Postmenopausal Women with Advanced Breast Cancer (2002) (1)
Vindesine: Phase II evaluation in colon cancer and description of its platelet stimulating activity (2004) (1)
FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. (2022) (1)
FDA breakthrough therapy designation of oncology products: The first-year experience. (2014) (1)
Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond (2022) (1)
Tumor progression versus bone scan “flare” in new lesions detected on early bone scans in patients with chemo-naïve metastatic castration resistant prostate cancer (mCRPC) treated with placebo or enzalutamide. (2016) (1)
FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple Negative Breast Cancer. (2022) (1)
Introduction. Beyond 5-fluorouracil. (1999) (1)
Anal canal and esophageal squamous cell carcinomas: the role of combined modality treatment (1987) (1)
Setting the Record Straight on FDA Approvals in Oncology. (2017) (1)
The Evolution of the Drug Evaluation Process in Oncology: Regulatory Perspective (2018) (1)
Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014). (2016) (1)
Food and Drug Administration Approval : Ofatumumab the Treatment of Patients with Chronic Lymphocytic R kemia Refractory to Fludarabine and Alemtuzumab (2010) (1)
Special protocol assessments: 10 years of experience in FDA’s Office of Hematology and Oncology Products. (2014) (1)
Abstract PD2-07: Prediction of CDK inhibitor efficacy in ER+/HER2- breast cancer using machine learning algorithms (2020) (1)
Perspectives on Drug Development in Multiple Myeloma—Looking Forward to 2025 (2021) (1)
Capecitabine: A Viewpoint by Richard Pazdur (1999) (1)
FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. (2022) (1)
The Role of Acute Myeloid Leukemia Minimal Residual Disease in Regulatory Decision-making. (2021) (1)
FDA Oncology Center of Excellence Review Processes and Tools. (2020) (1)
Approval : Alectinib for the Treatment of Metastatic ALK-Positive Non – Small Cell Lung Cancer Following (2016) (1)
U.S. Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission. (2019) (1)
Clinical pharmacology of 11-acetyl-8-carbamoyloxymethyl-4-formyl-14-oxa-1,11-diazatetracyclo (7.4.1.0(2,7).0(10,12) tetradeca-2,4,6-trien-6,9-diyl diacetate (FK 973). (1993) (1)
Survival benefit of nephrectomy prior to immunotherapy-based combinations in patients with metastatic renal cell carcinoma: An FDA pooled analysis. (2021) (1)
Expediting the availability of drugs for US patients with cancer (2008) (1)
FDA Analysis of Outcomes in Older Adults with Relapsed or Refractory Multiple Myeloma (2018) (1)
Non-proportional hazards – An evaluation of the MaxCombo Test in cancer clinical trials (2021) (1)
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 fusion or other rearrangement. (2022) (1)
The Jim interview. (2004) (0)
Designing Dose-Optimization Studies in Cancer Drug Development: Discussions with Regulators (2023) (0)
U.S. FDA Approval Summary: Abiraterone Acetate (2013) (0)
Overall survival in patients with breast cancer treated with a CDK 4/6 inhibitor plus fulvestrant: A U.S. Food and Drug Administration pooled analysis. (2021) (0)
Question-and-Answer Session (2007) (0)
Abstract 3516: A genomics model to predict immune-related adverse events in cancer patients treated with checkpoint inhibitors (2019) (0)
972 Phase I study of cyclophosphamide and docetaxel (taxotere®) in solid tumors (1995) (0)
Working conference on biomodulator and chemotherapy combination therapies (1991) (0)
The relationship of delay in time to deterioration of chest pain, cough and dyspnea with radiographic response with targeted therapies (TT) and chemotherapy (CT) in NSCLC. (2015) (0)
Report from the FDA Approval Summary: Docetaxel in Combination with Prednisone for the Treatment of Androgen-Independent Hormone-Refractory Prostate Cancer (2004) (0)
Pain medication use in patients with HR+, HER2-neg advanced breast cancer treated with endocrine therapy and a CDK 4/6 inhibitor: A U.S. FDA pooled analysis. (2020) (0)
Association between past medical history (PMH) of autoimmune events and adverse events of special interest (AESI). (2019) (0)
FDA Oncology Center of Excellence crowdsourcing initiative: outreach to the scientific community to identify research questions for pooled analyses of oncology clinical trial data. (2023) (0)
The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology (2021) (0)
US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer (2023) (0)
Targeted cancer therapies: FDA approval overview. (2010) (0)
Phase II Trial of Isotretinoin and Recombinant Interferon Alfa‐2a in Metastatic Colorectal Carcinoma (1995) (0)
Causes of patient ineligibility in clinical trials of metastatic urothelial cancer. (2019) (0)
Recent advances in colorectal chemotherapy: oral fluorinated pyrimidines, oxaliplatin and irinotecan. (2000) (0)
Eligibility criteria and Enrollment of a Diverse Racial and Ethnic population in Multiple Myeloma Clinical Trials. (2023) (0)
U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapyâ•’NaÃ ̄ve Metastatic Castrationâ•’Resistant Prostate Cancer (2015) (0)
56 Results of preoperative radiation and UFT, an oral fluorinated pyrimidine, plus leucovorin in locally advanced rectal cancer—A pilot study (1999) (0)
Characteristics of breakthrough therapy designation requests (BTDRs) submitted to the Office of Hematology and Oncology Products (OHOP), FDA. (2017) (0)
Special Considerations in Radiation Therapy Trials (2018) (0)
Response toNeoadjuvant ChemotherapyBest Predicts SurvivalAfterCurative Resection of Gastric Cancer (1999) (0)
FDA Approval Summary: Belzutifan for VHL Disease Tumors-Response. (2023) (0)
Developing a Genomics Model to Predict Failure of Isocitrate Dehydrogenase (IDH) Inhibitors for Treatment of Patients with IDH1- or IDH2-Mutated Acute Myeloid Leukemia (2018) (0)
Immunotherapy for Patients With Small-Cell Lung Cancer-2 Gains, 2 Losses. (2021) (0)
Phase I S tudy o f P reoperative O ral U racil a nd T egafur Plus L eucovorin a nd R adiation T herapy i n R ectal C ancer (2000) (0)
Temporal trends in oncology product approvals in the United States, 1986-2005. (2006) (0)
Differences in prior estrogen exposure may explain the difference in magnitude of breast cancer risk reduction observed in raloxifene breast cancer prevention trials (2008) (0)
FDA Approval Summary: Ripretinib for advanced gastrointestinal stromal tumor. (2022) (0)
Oral Therapy for Colorectal Cancer: How to Choose (2000) (0)
Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma (2023) (0)
FDA Oncology Center of Excellence Moves Forward on Coordinated Clinical Reviews, Integrated Approach to the Clinical Evaluation of Oncology Products (2017) (0)
Endpoints used by the FDA for new drug approvals for treatment (TT) of advanced (ADV) cancer: Example of hormone refractory prostate cancer (HRPC) (2005) (0)
Abstract PD4-08: An FDA analysis of survival outcomes comparing adjuvant paclitaxel and trastuzumab trial (APT) to an external control from historical clinical trials (2020) (0)
Response Rate, Event-Free Survival (EFS) and Overall Survival (OS) in Higher-Risk Myelodysplastic Syndromes (HR-MDS): U.S. Food and Drug Administration (FDA) Patient-Level Analyses (2021) (0)
An updated analysis of new oncologic drug approvals at FDA by expedited program. (2018) (0)
Abstract 5141: T-cell receptor repertoire analysis by next-generation sequencing peripheral blood mononuclear cells from multiple myeloma or smoldering multiple myeloma patients (2019) (0)
Report from the FDA Approval Summary for Bortezomib for Injection in the Treatment of Multiple Myeloma (2004) (0)
Regulatory Approvals of Pediatr ic Oncology Drugs : Prev ious (2003) (0)
Collection of grade 3/4 adverse event (AE) data in a subgroup of patients in cancer clinical trials supporting supplemental indications: A comprehensive analysis. (2015) (0)
FDA analysis: Demographic trends in bladder and renal cancer trials. (2019) (0)
Early targeted drug development: Pilot FDA review of PI3K inhibitor phase I studies using a knowledge management database. (2011) (0)
Commentary (Pazdur): New Anticancer Agents in Clinical Development (1995) (0)
US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer. (2023) (0)
Abstract P5-17-01: A definition of a high-risk early-breast cancer population based on data from the collaborative trials in neoadjuvant breast cancer (CTNeoBC) meta-analysis (2013) (0)
Management of toxicity: Approval of UGT1A1 genetic test and irinotecan label update (2006) (0)
Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy. (2017) (0)
FDA analysis of the characteristics and relevance of serious adverse events that are Grade 1 or 2 in severity. (2016) (0)
Sequential B iochemical M odulation o f F luorouracil W ith Folinic A cid, N -Phosphonacetyl -L-Aspartic A cid, a nd Interferon A lfa-2a i n A dvanced C olorectal C ancer (1999) (0)
Abstract B83: Survival of ethnic and racial minority patients with multiple myeloma treated with first-generation immunomodulatory and proteasome-inhibiting medications (2018) (0)
Book Review Colorectal Cancer By Maurizio Ponz de Leon. 303 pp., illustrated. New York, Springer-Verlag, 2002. $119. 3-540-43047-4 (2002) (0)
Milestone analyses with immune checkpoint inhibitors (ICI), targeted therapy (TT), and standard therapy in metastatic non-small cell lung cancer (mNSCLC) trials submitted to the U.S. FDA: An updated pooled analysis. (2016) (0)
Gender, age, and ethnic representation in non-small cell lung cancer (NSCLC) U.S. registration trials: FDA review. (2011) (0)
Phase II trial of intravenous melphalan in advanced colorectal carcinoma (2004) (0)
FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity. (2023) (0)
Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators (2022) (0)
FDA and Its Role in Drug Development (2021) (0)
CAPECITABIN : EIN ORALES FLUOROPYRIMIDIN (1998) (0)
Oncology Expanded Access and FDA's Project Facilitate. (2021) (0)
Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy. (2017) (0)
Preclinical Pharmacology and Phase I Clinical Trials of Taxotere R (RP 56976, NSC 628503) (1994) (0)
NEWS ew Off i ce and New Leader Aim To Streamline FDA Cancer Drug Review Process Change Amid Controversy (2005) (0)
FDA Comments on Article on Oncologic Drugs Advisory Committee Chairs (2002) (0)
FDA Analysis: Impact of Body Mass Index (BMI) on Outcomes in Relapsed-Refractory Multiple Myeloma (2019) (0)
Patient-reported pain and pain medication impact in patients with HR+ Her2-neg advanced breast cancer: A U.S. FDA pooled analysis. (2020) (0)
Treatment-related toxicity and improved outcomes with immune checkpoint inhibitors in patients with hepatocellular carcinoma. (2021) (0)
Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival. (2023) (0)
FDA Approval Summary: Atezolizumab as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC. (2023) (0)
Folo with U.S (2010) (0)
Project facilitate: Innovation and advancement in FDA’s oncology expanded access program. (2022) (0)
Reply to Letter to the Editor (2014) (0)
Reexamination of Patient Autonomy and Prior Therapies in Oncology Clinical Trial Eligibility Criteria. (2022) (0)
Bringing Safe and Effective Therapies to Premenopausal Women with Breast Cancer: Efforts to Broaden Eligibility Criteria. (2021) (0)
Emerging oncology drug targets in the 21st century: An FDA analysis. (2020) (0)
Overall Survival in Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Treated with a CDK 4/6 Inhibitor Plus Fulvestrant: A U.S. Food and Drug Administration Pooled Analysis (2021) (0)
Beyond 5-Fluorouracil (1999) (0)
A U.S. Food and Drug Administration (FDA) pooled analysis of outcomes for bone only metastatic breast cancer (MBC). (2016) (0)
Title: FDA Approval Summary: Pembrolizumab for the treatment of microsatellite instability- high solid tumors Running Title: FDA Approval Summary: Pembrolizumab for MSI-H solid tumors (2019) (0)
Impact of an evolving regulatory landscape on skin cancer drug development in the U.S. (2022) (0)
An Analysis of Recent FDA Oncology Scientific Publications. (2020) (0)
Targeted therapy approvals: Summary and future directions. (2014) (0)
Capecitabine, a n O ral F luoropyrimidine C arbamate W ith Substantial A ctivity i n A dvanced C olorectal C ancer: Results o f a R andomized P hase I I S tudy (2000) (0)
Updated FDA pooled analysis of pain medication use in trial participants with HR+, HER2-negative metastatic breast cancer treated with endocrine therapy and a CDK 4/6 inhibitor. (2022) (0)
An analysis of deficiencies identified during investigational new drug (IND) application reviews by the Division of Drug Oncology Products (DDOP) of the US FDA. (2006) (0)
FDA Approval Summary: Nivolumab for adjuvant treatment of adults with completely resected esophageal/gastroesophageal junction cancer and residual pathologic disease. (2022) (0)
Expert Opinion on Investigational Drugs (1999) (0)
Metastasis free survival in older men with nonmetastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: An FDA-pooled analysis. (2020) (0)
Addressing Barriers to Clinical Trial Participation for Transgender People With Cancer to Improve Access and Generate Data. (2022) (0)
Cancer Clinical Trials Beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion (2022) (0)
Anti-PD-1 antibody treatment for melanoma - Authors' reply. (2018) (0)
32 The point of view of FDA (2010) (0)
Approvals in 2022: overall survival, dose optimization, new approvals and beyond (2023) (0)
Reply to H. McLeod et al. (2019) (0)
Sorafenib for theTreatment of Advanced Renal Cell Carcinoma (2006) (0)
Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective. (2023) (0)
Utility of photography to confirm skin lesion response assessed using a severity weighted assessment tool (SWAT) in cutaneous T-cell lymphoma (CTCL) (2007) (0)
Postmarketing re-evaluation of irinotecan plus 5-fluorouracil/leucovorin for first-line treatment of metastatic colorectal cancer. (2002) (0)
FDA Analysis of Survival Outcomes in Older Adults with Relapsed-Refractory Multiple Myeloma (RRMM) Treated with Novel Drug Regimens (2019) (0)
End P oints a nd U nited S tates F ood a nd D rug A dministration Approval o f O ncology D rugs (2003) (0)
FDA accelerated approval of anticancer agents. (2010) (0)
Targeted therapies for the treatment of non-small cell lung cancer: Bull’s eye or missed target? (2012) (0)
Summary : Sunitinib for the Treatment of Progressive Well-Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors (2012) (0)
The FDA Division of Oncology Initiative with the NCI SBIR/ STTR Programs (2005) (0)
Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer. (2021) (0)
Pharmacology of i.v. amphotericin B (AmB) in mouse and humans and potentiation of CCNU cytotoxicity in AKR mouse (1985) (0)
Response Prediction to Isocitrate Dehydrogenase (IDH) Inhibitors in Patients with IDH1- or IDH2-Mutated Acute Myeloid Leukemia Using Clinical and Genomic Data (2021) (0)
Combination of Fluorouracil and Interferon: Mechanisms of Interaction and Clinical Studies (1992) (0)
Regulatory Issues : FDA U . S . Food and Drug Administration Approval Summary : Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed (2016) (0)
PCNU: Phase II evaluation in advanced colorectal carcinoma (1988) (0)
Oncology drug review process. (2003) (0)
FDA Analysis of Screen Failures By Race in Clinical Trials of Acute Myeloid Leukemia (2020) (0)
Contents, Supplement 1, 1997 (1997) (0)
Report from the FDA Approval Summary: Gemtuzumab Ozogamicin in Relapsed Acute Myeloid Leukemia (2001) (0)
Regulatory A pprovals o f P ediatric O ncology D rugs: P revious Experience a nd N ew I nitiatives (2003) (0)
Role of the US Food and Drug Administration in Cancer Drug Development (2011) (0)
Report from the FDA Fulvestrant in Postmenopausal Women with Advanced Breast Cancer (2003) (0)
Should Health-Related Quality of Life Be Measured in Cancer Symptom Management Clinical Trials? Lessons Learned Using the Functional 53 (2007) (0)
FDA pooled analysis of time to treatment discontinuation (TTD) in frontline advanced renal cell carcinoma trials. (2020) (0)

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