R
Richard Pazdur
Researcher at Center for Drug Evaluation and Research
Publications - 306
Citations - 26702
Richard Pazdur is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Medicine & Clinical trial. The author has an hindex of 83, co-authored 237 publications receiving 23032 citations.
Papers
More filters
Journal ArticleDOI
Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials A Meta-analysis
Jenny J. Zhang,Huanyu Chen,Kun He,Shenghui Tang,Robert Justice,Patricia Keegan,Richard Pazdur,Rajeshwari Sridhara +7 more
TL;DR: The results support the claim that a complete review of all radiographs by BICR may not be necessary for oncology trials, and alternative methods should be explored to evaluate bias.
Journal ArticleDOI
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.
Oladimeji Akinola Akinboro,Jonathon Joseph Vallejo,Erica C. Nakajima,Yi Ren,Pallavi S. Mishra-Kalyani,Erin A. Larkins,Paz Vellanki,Nicole L. Drezner,Luckson Mathieu,Martha Donoghue,Shenghui Tang,Richard Pazdur,Julia A. Beaver,Harpreet Singh +13 more
TL;DR: It is suggested that most subgroups of patients with advanced NSCLC with PD-L1 score ≥50% receiving FDA-approved chemo-IO regimens may have OS and PFS outcomes that are comparable with or better than IO-only regimens.
Journal ArticleDOI
Response Rate as an Approval End Point in Oncology: Back to the Future.
Journal ArticleDOI
Pilot phase II trial of 13-cis-retinoic acid and interferon-α combination therapy for advanced pancreatic adenocarcinoma
Dennis F. Moore,Richard Pazdur,Steve Sugarman,Dennie V. Jones,Scott M. Lippman,Beth Bready,James L. Abbruzzese +6 more
TL;DR: A pilot phase II trial of 13-cis-retinoic acid and IFN alpha in patients with advanced pancreatic adenocarcinomas found no objective responses occurred, and the toxicities were mild and reversible, and grade 3 fatigue occurred in only one patient.
Journal Article
Deferasirox for the Treatment of Chronic Iron Overload in Transfusional Hemosiderosis
George Shashaty,Raymond Frankewich,Tamal Chakraborti,Jasti Choudary,Suliman Al-fayoumi,Alice Kacuba,Sonia Castillo,Kathy Robie-Suh,Dwaine Rieves,Karen D. Weiss,Richard Pazdur +10 more
TL;DR: The FDA granted deferasirox accelerated approval on November 2, 2005, for use in treating chronic iron overload due to transfusional hemosiderosis in patients > or =2 years of age and the sponsor must obtain clinical data demonstrating the drug's long-term safety and effectiveness.