Durvalumab Approval Withdrawn for Urothelial Carcinoma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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