Merck Receives FDA Approval for Keytruda in Biliary Tract Cancer

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) in combination with gemcitabine and cisplatin for the treatment of adults with locally advanced unresectable or metastatic biliary tract cancer (BTC). In the Phase 3 KEYNOTE-966 trial, the combination demonstrated a statistically significant improvement in overall survival compared to gemcitabine and cisplatin alone. The median OS was 12.7 months for KEYTRUDA plus chemotherapy versus 10.9 months for chemotherapy alone. This approval provides a new first-line treatment option for patients with this aggressive cancer type.