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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FDA Approval Summary: Vorinostat for Treatment of Advanced Primary Cutaneous T-Cell Lymphoma
TL;DR: On October 6, 2006, the U.S. Food and Drug Administration granted regular approval to vorinostat (Zolinza(R); Merck & Co., Inc., Whitehouse Station, NJ), a histone deacetylase inhibitor, for the treatment of cutaneous manifestations of Cutaneous T-cell lymphoma in patients with progressive, persistent, or recurrent disease on or following two systemic therapies.
Journal Article
Approval Summary: Gemtuzumab Ozogamicin in Relapsed Acute Myeloid Leukemia
Peter F. Bross,Julie Beitz,Gang Chen,Xiao Hong Chen,Eric Duffy,Lydia Kieffer,S K Roy,Rajeshwari Sridhara,Atiqur Rahman,Grant R. Williams,Richard Pazdur +10 more
TL;DR: Tolerability and ease of administration may be improved compared with conventional chemotherapy, except for hepatotoxicity, with 31% of patients exhibiting abnormal liver enzymes, and the reduction of leukocyte counts to below 30,000/ml is recommended prior to treatment.
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Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration
TL;DR: Elderly were under-represented in the registration trials of new cancer therapies and various strategies may be needed to evaluate cancer therapies for the elderly in prospective clinical trials and to improve cancer care in the elderly population.
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Velcade®: U.S. FDA Approval for the Treatment of Multiple Myeloma Progressing on Prior Therapy
TL;DR: The most clinically relevant adverse events were asthenic conditions, nausea, vomiting, diarrhea, thrombocytopenia, and a peripheral neuropathy that often was painful.
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FDA Drug Approval Summary: Bevacizumab (Avastin®) as Treatment of Recurrent Glioblastoma Multiforme
TL;DR: The attribution of certain adverse events to either bevacizumab, underlying disease, or both could not be determined because of the single-arm, noncomparative study design.