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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First FDA Approval of Neoadjuvant Therapy for Breast Cancer: Pertuzumab for the Treatment of Patients with HER2-Positive Breast Cancer
Laleh Amiri-Kordestani,Suparna Wedam,Lijun Zhang,Shenghui Tang,Amy Tilley,Amna Ibrahim,Robert Justice,Richard Pazdur,Patricia Cortazar +8 more
TL;DR: The most common adverse reactions with PTD were alopecia, diarrhea, nausea, and neutropenia, while the pathologic complete response rates by the FDA-preferred definition of invasive cancer in the breast and lymph nodes were 39.3% and 21.5% in the PTD and the TD arms, respectively.
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FDA Report: Eculizumab (Soliris®) for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria
Andrew Dmytrijuk,Kathy Robie-Suh,Martin H. Cohen,Dwaine Rieves,Karen D. Weiss,Richard Pazdur +5 more
TL;DR: Eculizumab was studied in a randomized, double-blind, placebo-controlled clinical trial in 87 RBC transfusion-dependent adult PNH patients and in a supportive single-arm study in 96 patients, with significant findings included the development of human anti-human antibody responses in three patients and serious meningococcal infections inThree patients.
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FDA Approval Summary: Nivolumab for the Treatment of Relapsed or Progressive Classical Hodgkin Lymphoma
TL;DR: The U.S. Food and Drug Administration granted accelerated approval for nivolumab for the treatment of patients with classical Hodgkin L that has relapsed or progressed after autologous HSCT and post‐transplantation brentuximab vedotin on May 17, 2016.
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U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis
Albert Deisseroth,Edvardas Kaminskas,Joseph A. Grillo,Wei Chen,Haleh Saber,Hong L. Lu,Mark D. Rothmann,Satjit Brar,Jian Wang,Christine Garnett,Julie Bullock,Laurie B. Burke,Atiqur Rahman,Rajeshwari Sridhara,Ann T. Farrell,Richard Pazdur +15 more
TL;DR: Ruxolitinib treatment was associated with an increased incidence of grades III and IV anemia, thrombocytopenia, and neutropenia and is the first drug approved for myelofibrosis.
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FDA Drug Approval Summaries: Pemetrexed (Alimta®)
TL;DR: The purpose of this report is to summarize information on pemetrexed (LY231514; MTA; Alimta; Eli Lilly and Company; Indianapolis, IN), a drug recently approved by the U.S. Food and Drug Administration (FDA).