AstraZeneca's Imfinzi/Chemo Combo Goes Under Priority FDA Review For Bile Duct Cancer

  • The FDA has accepted AstraZeneca plc’s (NASDAQ) supplemental marketing application seeking approval for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, for locally advanced or metastatic biliary tract cancer (BTC).
  • Under the Priority Review status, the FDA action date is during the third quarter of 2022.
  • BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. 
  • The application was based on an interim analysis of the TOPAZ-1 Phase 3 trial. 
  • Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% versus chemotherapy alone. An estimated one in four (25%) patients treated with Imfinzi plus chemotherapy were alive at two years compared to one in 10 (10%) treated with chemotherapy alone.
  • Results also showed a statistically significant 25% reduction in disease progression or death risk with Imfinzi plus chemotherapy. 
  • The Imfinzi combination was generally well tolerated and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone.
  • Price Action: AZN shares closed 1.11% higher at $67.17 on Tuesday.
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