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EMA Committee Recommends Approval of Keytruda in MSI-H Colorectal Cancer

NEW YORK – Merck said on Friday that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for pembrolizumab (Keytruda) as a first-line option for metastatic colorectal cancer patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

CHMP issued the positive opinion after reviewing the results of the Phase III Keynote-177 trial comparing pembrolizumab against investigators' choice of chemotherapy alone or a chemotherapy-based regimen that included bevacizumab (Genentech's Avastin) or cetuximab (Eli Lilly's Erbitux). Median progression-free survival was 16.5 months in the patients who received pembrolizumab and 8.2 months in patients who received the standard of care. Among the patients who responded to treatment with pembrolizumab, 43 percent experienced a duration of response lasting two years or longer.

Between 5 percent and 15 percent of colorectal cancer patients are MSI-H or dMMR.

"Patients in Europe with MSI-H/dMMR colorectal cancer have had only chemotherapy-containing regimens available to them in the first-line treatment setting and have historically faced poor outcomes," Vicki Goodman, VP of clinical research at Merck Research Laboratories, said in a statement. "This positive EU CHMP opinion reinforces the potential of KEYTRUDA as a new option for patients with MSI-H/dMMR colorectal cancer and illustrates our ongoing commitment to pursuing biomarker research to help address the needs of patients who have few effective options."

The European Commission will review CHMP's recommendation and is slated to issue a final decision in the first quarter of 2021.The US Food and Drug Administration approved pembrolizumab for this same indication in June based on Keynote-177 data.