Merck gets positive EMA Committee opinion for Keytruda plus Gemcitabine, Cisplatin for Biliary Tract Cancer

The recommendation is based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the fourth quarter of 2023.

In October 2023, the U.S. Food and Drug Administration (FDA) approved the use of KEYTRUDA in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

Biliary tract cancer is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Biliary tract cancer is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for approximately 15% of all liver cancers. It is estimated there are approximately 211,000 patients diagnosed with BTC and 174,000 patient deaths from the disease each year globally. Biliary tract cancer is most frequently diagnosed in patients between 50 and 70 years old, and approximately 70% of BTC patients are diagnosed at an advanced stage. Patients diagnosed with BTC face a very poor prognosis, with a five-year relative survival rate of 5-15% across all patients.

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