CHMP positive opinion for Keytruda (pembrolizumab) + gemcitabine + cisplatin as first-line treatment for locally advanced unresectable or metastatic biliary tract cancer- Merck Inc.
Merck Inc., known as MSD outside of the United States and Canada, has announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
“Patients diagnosed with locally advanced unresectable or metastatic biliary tract cancer face a challenging disease with poor survival outcomes, underscoring the need for new treatment options that may help extend their lives,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “The CHMP’s positive opinion brings us one step closer to providing a new immunotherapy regimen, which has shown an overall survival benefit compared to chemotherapy alone, to these patients in the European Union.”
The recommendation is based on results from the Phase III 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 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.
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