Merck receives positive opinion from EMA for Keytruda

By The Science Advisory Board staff writers

March 30, 2022 -- Merck announced that it received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval for pembrolizumab (Keytruda) for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in five different types of cancer.

The anti-programmed death receptor-1 antibody is a monotherapy for the treatment of patients with unresectable or MSI-H/mismatch repair deficient colorectal, gastric, small intestine or biliary cancer, and advanced or recurrent MSI-H/dMMR endometrial carcinoma, the company said.

The CHMP recommendations were based on results from the phase II Keynote-158 and phase II Keynote-164 trials of Keytruda.

The agency’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 second quarter of 2022, Merck said in a release.

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