FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

AstraZenaca Earns Priority Review for Cancer Biologic Indication

Oct. 20, 2017
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The FDA granted priority review to the application for an additional indication for AstaZenaca’s Imfinzi (durvalumab), the company said.

The application is for approval of the biologic for patients with locally advanced (Stage III) unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.

Imfinzi was previously approved for 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.

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