Posted by Michael Wonder on 02 Sep 2022
FDA approves durvalumab for locally advanced or metastatic biliary tract cancer
2 September 2022 - Today the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.
Efficacy was evaluated in TOPAZ-1, a randomised, double-blind, placebo-controlled, multi-regional trial that enrolled 685 patients with histologically confirmed locally advanced unresectable or metastatic biliary tract cancer who had not previously received systemic therapy for advanced disease.
