FDA accepts application for Keytruda + chemotherapy as treatment for advanced or unresectable biliary tract cancer
Merck known as MSD outside of the United States and Canada, announced the FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC)
The sBLA is based on data from the KEYNOTE-966 trial, in which Keytruda plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone. Results from KEYNOTE-966 were presented at the American Association for Cancer Research (AACR) 2023 Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of February 7, 2024.
“Most biliary tract cancers go undetected until an advanced stage, at which point many patients are ineligible for surgery and have few treatment options,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We look forward to working with the FDA to bring a new option to patients with advanced or unresectable biliary tract cancer that may help them live longer.”
Merck has an extensive clinical development program evaluating Keytruda in gastrointestinal cancers, which includes KEYNOTE-937 in earlier-stage hepatocellular carcinoma (HCC), and in combination with Lenvima (lenvatinib, in collaboration with Eisai) and transarterial chemoembolization (TACE) in the LEAP-012 study. Merck is continuing to study Keytruda for multiple uses in hepatobiliary, esophageal, pancreatic, colorectal and gastric cancers.
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