Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer
Approval based on TOPAZ-1 Phase III trial results, which showed Imfinzi combination reduced risk of death by 20% vs. chemotherapy alone.AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin). The approval by the Food and Drug Administration (FDA) was based on the results from the TOPAZ-1 Phase III trial