Durvalumab Approval Withdrawn for Urothelial Carcinoma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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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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