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

The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca's 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.

The supplemental Biologics License Application (sBLA) was based on results from an interim analysis of the TOPAZ-1 Phase III trial, evaluating Imfinzi (durvalumab) presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium.

Susan Galbraith, Executive Vice President, Oncology R&D, said: "People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today's news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting”.

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company.

AstraZeneca is currently trading down 1 percent at $66.43 in the pre-market session.