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Pharmaceuticals / Submissions and Approvals

AstraZeneca’s Imfinzi Wins FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer

May 10, 2017
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The FDA has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab).

Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery.

Imfinzi is also under investigation in a Phase 3 Danube trial as a first-line treatment in urothelial carcinoma as a monotherapy and in combination with tremelimumab.

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