Enfortumab Vedotin for Advanced Urothelial Carcinoma With Peter H. O'Donnell, MD

The FDA recently approved enfortumab vedotin (Padcev®, Astellas Pharma US, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after treatment with platinum-based chemotherapy and anti–programmed cell death protein 1 (anti–PD-1) or anti–programmed death ligand 1 (anti–PD-L1) therapy. The approval was based on EV-201, a phase 2 trial in which enfortumab vedotin produced a high rate of response in patients with locally advanced or m...
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Avapritinib Approved: Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation

​The FDA has approved avapritinib (AyvakitTM, Blueprint Medicines) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) with platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, including D842V mutations, the most common type of exon 18 mutation. Up to 10% of patients with GIST harbor PDGFRA mutations, which have been linked to GIST development."GIST harboring a PDGFRA exon 18 mutation do not respond to standard therapies for GIST," commented Rich...
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Pembrolizumab Approval: Non-Muscle Invasive Bladder Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary tumors. Pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, is indicated for patients who are ineligible for or have elected not to receive radical cystectomy and who do not respond to bacillus Calmette-Guérin (BCG) therapy.The approval was based on Keynote 057 (NCT02625961), a multicenter, single...
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Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer: Andrew J. Armstrong, MD, MSc

​The FDA recently added a new approval of enzalutamide (Xtandi®, Astellas Pharma Inc.) for the treatment of metastatic castration-sensitive prostate cancer, based on data from the ARCHES and ENZAMET trials. In this interview with i3 Health, Andrew J. Armstrong, MD, MSc, lead researcher of the phase 3 ARCHES trial, discusses the approval's significance and compares the variety of options that are now available for the treatment of metastatic hormone-sensitive disease.What are the greatest challen...
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Olaparib Approval: BRCA-Mutated Metastatic Pancreatic Cancer

The FDA has now approved olaparib (Lynparza®, AstraZeneca) for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma who have not experienced disease progression after at least 16 weeks of a first-line platinum-based chemotherapy regimen. In addition, the FDA approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with deleterious or suspected ...
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