1 November 2023 - On 31 October 2023, the FDA approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer.
Efficacy was evaluated in KEYNOTE-966, a multi-centre, randomised, double-blind, placebo-controlled trial that enrolled 1069 patients with locally advanced unresectable or metastatic biliary tract cancer who had not received prior systemic therapy for advanced disease.