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Benzinga
Benzinga
Technology
Ragothaman Srinivasan

FDA Accepts AstraZeneca's sBLA for Imfinzi (durvalumab) in biliary tract cancer (BTC) with Priority Review

AstraZeneca FDA Cancer Nasdaq Chemotherapy Oncology

The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca's (NASDAQ:AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy and granted Priority Review for patients with locally advanced or metastatic biliary tract cancer (BTC).

The action date for the regulatory decision is scheduled for the third quarter of 2022.

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