AstraZeneca's Imfinzi granted priority review in the US
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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.
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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.