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.
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Journal ArticleDOI
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments
Suparna Wedam,Julia A. Beaver,Laleh Amiri-Kordestani,Erik Bloomquist,Shenghui Tang,Kirsten B. Goldberg,Rajeshwari Sridhara,Amna Ibrahim,Geoffrey Kim,Paul G. Kluetz,Amy E. McKee,Richard Pazdur +11 more
TL;DR: The largest analysis to date of the BO subgroup of MBC suggests this subgroup may have a distinct natural history and there seems to be a difference in how the local investigators assessed progression events in theBO subgroup when compared with the other two groups.
Journal ArticleDOI
Approvals in 2016: the march of the checkpoint inhibitors.
TL;DR: In 2016, FDA Oncology approved five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews, and 11 approvals of breakthrough-designated therapies.
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FDA Approval Summary: Belzutifan for von Hippel-Lindau disease associated tumors.
Jaleh Fallah,Michael Brave,Chana Weinstock,Gautam U. Mehta,Diana Bradford,Haley Gittleman,Erik Bloomquist,Rosane Charlab,Salaheldin S. Hamed,Claudia P. Miller,Sarah E. Dorff,Wiley A. Chambers,Bronwyn D Mixter,Jeannette Dinin,William F. Pierce,Tiffany K. Ricks,Shenghui Tang,Martha Donoghue,Richard Pazdur,Laleh Amiri-Kordestani,Amna Ibrahim,Julia A. Beaver +21 more
TL;DR: Belzutifan can render some hormonal contraceptives ineffective and can cause embryo-fetal harm during pregnancy, and the FDA thought process supporting traditional approval of belzut ifan for this indication is summarized.
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FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer
Melanie Royce,Christy L. Osgood,Flora Mulkey,Erik Bloomquist,William F. Pierce,Ankhi Roy,Shyam Kalavar,Soma Ghosh,Reena Philip,Fatima Rizvi,Bronwyn D Mixter,Shenghui Tang,Richard Pazdur,Julia A. Beaver,Laleh Amiri-Kordestani +14 more
TL;DR: The approval of abemaciclib in adjuvant EBC was limited to patients with high risk of recurrence and Ki-67 ≥ 20%, given their favorable benefit:risk with a statistically significant IDFS advantage and no observed detriment on survival.
Journal ArticleDOI
Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer.
Jonathan P. Jarow,V. Ellen Maher,Shenghui Tang,Amna Ibrahim,Geoffrey Kim,Rajeshwari Sridhara,Richard Pazdur +6 more
TL;DR: Important aspects of the design and conduct of clinical trials to develop new therapies for patients with non-muscle invasive bladder cancer and to obtain marketing approval are outlined.