4th May 2022 07:42
(Sharecast News) - Drugmaker AstraZeneca said on Wednesday that a supplemental biologics license application for its Imfinzi asset, in combination with standard-of-care chemotherapy, had been accepted and granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer.
AstraZeneca stated the US Food and Drug Administration had approved the application based on results from an interim analysis of the TOPAZ-1 Phase III trial on the drug.
The FDA's action date for its regulatory decision will be during the third quarter of 2022.
Susan Galbraith, AstraZeneca's executive vice president of 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.
"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."
As of 0950 BST, AstraZeneca shares were down 0.58% at 10,622.0p.