The FDA approved durvalumab (Imfinzi, AstraZeneca) for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine [Gemzar, Eli Lilly] plus cisplatin).
The approval was based on the results from the TOPAZ-1 phase 3 trial. In an interim analysis, durvalumab plus chemotherapy reduced the risk for death by 20% compared with chemotherapy alone (hazard ratio [HR], 0.80; 95% CI, 0.66-0.97; P=0.021). An estimated one in