AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC).
The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.
FDA has set a Prescription Drug User Fee Act date for the third quarter of 2022.
Roughly 23,000 people in the U.S. receive a BTC diagnosis annually. Of those, approximately 5% to 15% survive five years after diagnosis.
“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,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca: “We are working close…