FDA OK’s Keytruda in Biliary Tract Cancer

FDA has approved Merck’s Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). Approval was based on data from KEYNOTE-966 (NCT04003636), a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 1,069 patients with locally advanced unresectable or metastatic BTC who had not received prior systemic therapy for advanced disease. “Pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in OS [overall survival] compared to placebo plus chemotherapy…,” an agency news release says.

FDA says that adverse reactions leading to Keytruda interruption occurred in 55% of patients, with the most common reactions or laboratory abnormalities being “decreased neutrophil count, decreased platelet count, anemia, decreased white blood cell count, pyrexia, fatigue, cholangitis, increased ALT, increased AST, and biliary obstruction.”