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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New Durvalumab Dosing Schedule Approved for Urothelial Carcinoma and Non-Small Cell Lung Cancer

 The FDA recently approved new doses of durvalumab (Imfinzi®, AstraZeneca) for the treatment of patients with previously treated advanced urothelial carcinoma and unresectable stage III non-small cell lung cancer. "Durvalumab, a selective, high-affinity, engineered human IgG1 mAb that blocks PD-L1 binding to PD-1 and CD80, is approved in the US, Japan, and several other countries for the treatment of patients with unresectable, stage III NSCLC whose disease has not progressed following conc...

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Avelumab for Urothelial Carcinoma: An Interview With Thomas Powles, MBBS, MRCP, MD

The FDA recently approved avelumab (Bavencio®, EMD Serono, Inc.) for patients with advanced urothelial carcinoma (UC). Thomas Powles, MBBS, MRCP, MD, discusses with i3 Health the implication of this approval and future steps for research and offers community oncologists advice on treating this patient population. What are the most challenging aspects of treating patients with locally advanced or metastatic UC? Thomas Powles, MBBS, MRCP, MD: The overall survival outcomes are poor for the disease....

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FDA Approves Avelumab for Advanced Urothelial Carcinoma

First-line cisplatin-based chemotherapy prolongs survival in patients with advanced urothelial carcinoma (UC), but disease progression usually occurs within 8 months, and currently no standard second-line therapies are available. Avelumab (Bavencio®, EMD Serono, Inc.), a fully human anti-PD-L1 IgG1 antibody, has shown to have an acceptable safety profile and success in treating this patient population. Based on this evidence, the FDA has now approved avelumab to treat patients with locally advan...

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Mitomycin C Hydrogel Approved: Low-Grade Upper Tract Urothelial Cancer

The FDA has now approved mitomycin C formulated with a reverse thermal hydrogel (JelmytoTM, UroGen Pharma) for the treatment of adults with low-grade upper tract urothelial cancer (UTUC). Accounting for 5% to 10% of all urothelial cancers, UTUC is a rare disease; low-grade UTUC occurs at an incidence of 6,000 to 8,000 cases per year in the United States. Mitomycin C hydrogel, the first drug to be approved specifically for low-grade UTUC, is an alkylating agent, a drug that halts protei...

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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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Enfortumab Vedotin Approved for Urothelial Carcinoma

​The FDA has approved enfortumab vedotin (Padcev®, Astellas Pharma US, Inc.) for patients with locally advanced or metastatic urothelial carcinoma. Enfortumab vedotin is indicated for patients whose disease progressed after prior 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. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule highly expressed in urothelial cancers, and is the first...

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