Merck & Co Inc (NYSE:MRK) announced Friday that its drug Keytruda has been backed by the European Medicines Agency’s Committee for Medicinal Products in Human Use (CHMP) for use in certain patients with biliary tract cancer.
The CHMP’s recommendation to approve Keytruda in combination with gemcitabine and cisplatin for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma will now be reviewed by the European Commission for marketing authorization in the European Union, with a final decision expected by the year-end.
“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,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research laboratories.
“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.”
Merck said the CHMP’s recommendation is based on positive overall survival rate results from its Phase 3 KEYNOTE-966 trial.
The study showed that Keytruda in combination with chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy on its own.
The drug in combination with gemcitabine and cisplatin was approved for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer by the United States Food and Drug Administration (FDA) in October 2023.
Merck shares added 0.8% to US$103.18 in premarket trade on the news.
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