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 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.”
An interim analysis of the TOPAZ-1 study showed that Imfinzi plus chemotherapy (gemcitabine plus cisplatin) cut the risk of death by 20% compared to chemotherapy alone.
The data indicated that the combination of Infinzi and chemotherapy led to a 25% reduction in the risk of disease progression or death compared to chemotherapy alone.
In September 2021, AstraZeneca announced that Imfinzi with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with metastatic non-small cell lung cancer based on the Phase 3 POSEIDON study.
Filed Under: Biologics, Oncology