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.