FDA Approves Pembrolizumab for Advanced/Metastatic Urothelial Carcinoma

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck) for the first-line treatment of patients with locally advanced/metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy. This regular approval comes after the FDA granted pembrolizumab accelerated approval. "Programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors are active in metastatic urothelial carcinoma," wrote Thomas Powles, MD, Professor of Genitourinary ...
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FDA Approves Nivolumab for High-Risk Urothelial Carcinoma

The FDA has granted regular approval to nivolumab (Opdivo®, Bristol Myers Squibb) as adjuvant therapy for patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. This is the first time the FDA has approved an adjuvant treatment for patients with high-risk urothelial carcinoma. Nivolumab had previously been granted accelerated approval for advanced and metastatic urothelial cancer. "In a phase 3, multicenter, double-blind, randomized, controlled t...
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FDA Approves Enfortumab Vedotin-Ejfv for Urothelial Cancer

The FDA has granted regular approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma US, Inc.) for patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy or those who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. "Patients with locally advanced or metastatic ur...
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Sacituzumab Govitecan for Advanced Urothelial Cancer: Petros Grivas, MD, PhD

Recently, the FDA granted accelerated approval to sacituzumab govitecan (Trodelvy®, Immunomedics), an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer whose disease progressed following treatment with platinum-containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitor. In this interview with Oncology Data Advisor, Dr. Petros Grivas, Associate Professor and Clinical Director of the Genitourinary Cance...
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FDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor. "Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors," wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on w...
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