BRIEF—Priority Review for Imfinzi in biliary tract cancer

A supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the USA.

The sBLA is based on results from an interim analysis of the TOPAZ-1 Phase III trial.

Developer AstraZeneca is bidding to broaden the label for the checkpoint blocker, to include treatment of people with locally advanced or metastatic biliary tract cancer (BTC), in combination with chemotherapy.

The decision means that the US Food and Drug Administration is expected to make a decision during the third quarter of 2022.

Executive vice president of oncology R&D Susan Galbraith 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.”

She added: “We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy.”