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NOVEMBER 1, 2023

FDA Approves Keytruda With Chemotherapy for Biliary Tract Cancer

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 multicenter, randomized, double-blind, placebo-controlled trial that enrolled 1,069 patients with locally advanced, unresectable or metastatic biliary tract cancer who had not received prior systemic therapy for advanced disease. Patients were randomized in a 1:1 fashion to receive either