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EMA's CHMP Issues Positive Recommendation for Merck's Keytruda in Specific MSI-H/dMMR Tumors

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday issued a positive opinion for Merck's Keytruda (pembrolizumab) as a treatment for patients with five types of advanced cancers characterized by high microsatellite instability or mismatch repair deficiency.

The committee recommended the PD-1 inhibitor for adult cancer patients with unresectable or metastatic colorectal cancer following fluoropyrimidine-based combination therapy; patients with advanced or recurrent endometrial carcinoma after a platinum-containing therapy in any setting, who can't have curative surgery or radiation; and patients with unresectable or metastatic gastric, small intestine, or biliary cancer after at least one prior therapy. Patients must have tumors that are MSI-high or dMMR.

The European Commission will now review CHMP's recommendation and issue a final decision in the second quarter of 2022. In Europe, Keytruda is already approved as a firstline treatment for metastatic colorectal cancer that is MSI-high or dMMR.

"This positive CHMP opinion reinforces the predictive value of MSI-H/dMMR across many different cancer types and the importance of biomarker testing," said Scot Ebbinghaus, VP of global clinical development at Merck Research Laboratories. "Keytruda has already become an important first-line treatment option for certain patients in Europe with MSI-H or dMMR colorectal cancer, and we are pleased the CHMP has recommended Keytruda as a monotherapy for additional patients with MSI-H or dMMR tumors."

The CHMP's recommendation departs from the US Food and Drug Administration, which in 2017 granted Keytruda accelerated approval for adult and pediatric patients with any refractory solid tumor that is MSI-high or dMMR, who have run out of treatment options. Merck said regulators in both the US and EU reviewed data from two Phase II studies: Keynote-158 and Keynote-164.