AstraZeneca's Imfinzi gets FDA priority review for biliary tract cancer
May 05, 2022 6:08 AM ETAstraZeneca PLC (AZN)By: Ravikash, SA News Editor
- 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.