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
Capecitabine, an Oral Fluoropyrimidine Carbamate With Substantial Activity in Advanced Colorectal Cancer: Results of a Randomized Phase II Study
Eric Van Cutsem,Michael Findlay,Osterwalder B,Walter Kocha,D. Dalley,Richard Pazdur,Jim Cassidy,Luc Dirix,Chris Twelves,David Allman,Jean-François Seitz,Jürgen Schölmerich,Hans Ulrich Burger,Jaap Verweij +13 more
TL;DR: The intermittent single-agent capecitabine schedule is proposed for phase III evaluation, based on considerations of toxicity, dose-intensity, response rate, and TTP.
Journal ArticleDOI
United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy
TL;DR: The results of the phase 3 trial and the FDA analysis of the data, along with the sponsor's completion of other postmarketing commitments, confirm bortezomib's benefit and support regular approval.
Journal ArticleDOI
Bortezomib for the treatment of mantle cell lymphoma.
Robert C. Kane,Ramzi Dagher,Ann T. Farrell,Chia-Wen Ko,Rajeshwari Sridhara,Robert Justice,Richard Pazdur +6 more
TL;DR: Bortezomib received regular approval for the treatment of patients with mantle cell lymphoma in relapse after prior therapy and was reviewed and marketing approval considerations for bortzomib were described.
Journal ArticleDOI
Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer
TL;DR: The FDA has issued guidance for using this end point in applying for accelerated drug approval for neoadjuvant trials, using the rate of pathological complete response as the primary end point.
Journal ArticleDOI
FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1
TL;DR: The data supporting the approval decision is discussed, specifically highlighting the incorporation of a companion diagnostic in the key study and the optimal dose of pembrolizumab.