AstraZeneca's Imfinzi gets FDA priority review for biliary tract cancer

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• The U.S. Food and Drug Administration granted priority review to AstraZeneca's (NASDAQ:AZN) Imfinzi, in combination with standard-of-care chemotherapy, to treat patients with locally advanced or metastatic biliary tract cancer (BCT).
• The British pharma giant said in a May 4 release that the FDA accepted its supplemental Biologics License Application (sBLA) and expects to make a decision in Q3 2022.
• Under priority review the FDA's goal is to take action on an application within six months, compared to 10 months under standard review.
• The application was backed by data from a phase 3 trial, dubbed TOPAZ-1.
• The company said BTC is a rare cancer that occur in the bile ducts and gallbladder.