Merck Receives FDA Approval for Keytruda Plus Chemotherapy in Biliary Tract Cancer

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) plus gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic biliary tract cancer. In the Phase 3 KEYNOTE-966 trial, KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival, with a median OS of 12.7 months versus 10.9 months for placebo plus chemotherapy. This approval establishes KEYTRUDA plus chemotherapy as a new standard of care in biliary tract cancer.