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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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FDA Drug Approval Summary: Bevacizumab Plus FOLFOX4 as Second-Line Treatment of Colorectal Cancer
TL;DR: Overall survival (OS), the primary study endpoint, was significantly longer for patients receiving bevacizumab in combination with FOLFOX4 than for those receiving FOL FOX4 alone.
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FDA Drug Approval Summary: Panitumumab (Vectibix™)
TL;DR: Panitumumab approval is based on the results of a single, open-label, randomized, multinational study that enrolled 463 patients with EGFR-expressing metastatic colorectal cancer.
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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
Gideon M. Blumenthal,Stella W. Karuri,Hui Zhang,Lijun Zhang,Sean Khozin,Dickran Kazandjian,Shenghui Tang,Rajeshwari Sridhara,Patricia Keegan,Richard Pazdur +9 more
TL;DR: A therapy in advanced NSCLC with a large magnitude of effect on ORR may have a large PFS effect, and the patient-level analysis showed that responders have a better PFS and OS compared with nonresponders.
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FDA Approval of Gefitinib for the Treatment of Patients With Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer
TL;DR: Efficacy results were supported by a retrospective exploratory analysis of a subset of a randomized, multicenter, open-label trial on 1,217 patients with metastatic NSCLC, and benefit–risk analysis was deemed favorable for FDA approval.
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FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
Geoffrey Kim,Amy E. McKee,Yang-Min Ning,Maitreyee Hazarika,Marc R. Theoret,John R. Johnson,Qiang Casey Xu,Shenghui Tang,Rajeshwari Sridhara,Xiaoping Jiang,Kun He,Donna Roscoe,W. David McGuinn,Whitney S. Helms,Anne Marie Russell,Sarah Pope Miksinski,Jeanne Fourie Zirkelbach,Justin C. Earp,Qi Liu,Amna Ibrahim,Robert Justice,Richard Pazdur +21 more
TL;DR: The most common adverse reactions in patients treated with vemurafenib were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, and nausea, and other adverse reactions included hypersensitivity, Stevens–Johnson syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and liver enzyme laboratory abnormalities.