AZN : Imfinzi Plus Chemotherapy Granted Priority Review In U.S. For Metastatic Biliary Tract Cancer

AstraZeneca Plc.'s (AZN.L,AZN) supplemental Biologics License Application or sBLA for Imfinzi or durvalumab, in combination with standard-of-care chemotherapy, has been accepted and granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the third quarter of 2022.

The supplemental Biologics License Application was based on results from an interim analysis of the TOPAZ-1 Phase III trial. The trial results showed improved overall survival with an immunotherapy added to chemotherapy over standard-of-care chemotherapy alone.

Biliary tract cancer is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.

In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of biliary tract cancer.

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