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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Shortfall in Knowledge Identified in Factors Used for Personalization of Urothelial Carcinoma Treatment

A shortfall in knowledge in the use of biomarkers and patient-related factors for the personalization of treatment for patients with advanced urothelial carcinoma was identified in the baseline data collected from i3 Health's continuing medical education (CME)–approved visiting faculty meeting series titled New Thinking, New Strategies in Advanced Urothelial Carcinoma, led by Arjun V. Balar, MD, Associate Professor of Medicine and Director of the Genitourinary Medical Oncology Program at NYU Lan...
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Enfortumab Vedotin for Urothelial Carcinoma: Thomas Powles, MD, MBBS, MRCP

For patients with locally advanced or metastatic urothelial carcinoma, treatment options are limited after progression on chemotherapy and immune checkpoint inhibitors, and survival rates remain low. In the phase 3 EV-301 trial, results of which were recently presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, enfortumab vedotin demonstrated promising efficacy in this patient population. In this interview with Oncology Data Advisor, Dr. Thomas Powles, D...
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Durvalumab Approval Withdrawn for Urothelial Carcinoma

Today, AstraZeneca voluntarily withdrew the indication of durvalumab (Imfinzi®, AstraZeneca) for patients with previously treated locally advanced or metastatic urothelial carcinoma based on results of the phase 3 DANUBE trial (NCT02516241), which did not meet its primary end points. The withdrawal does not affect durvalumab's indications for non-small cell lung cancer or for extensive stage small-cell lung cancer. Durvalumab, a human monoclonal antibody that binds to programmed death ligand 1 (...
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