KENILWORTH (NJ) (dpa-AFX) - Merck & Co. Inc. (MRK) said Tuesday that the European Commission has approved KEYTRUDA, Merck's anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
According to Merck, the approval marks the first gastrointestinal indication for KEYTRUDA in Europe, and makes KEYTRUDA the first anti-PD-1/L1 therapy approved in Europe for these patients.
The approval is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40 percent compared with chemotherapy.
Merck noted that in the trial, treatment with KEYTRUDA also more than doubled median progression-free survival or PFS compared with chemotherapy to 16.5 months versus 8.2 months.
Merck also said there was a lower incidence of Grade ?3 treatment-related adverse events or TRAEs with KEYTRUDA compared with chemotherapy, and no new toxicities were observed.
The European Commission approval allows marketing of KEYTRUDA monotherapy in all 27 European Union or EU member states plus Iceland, Lichtenstein, Norway and Northern Ireland. Following Brexit, in line with the reliance route, this approval is also valid in Great Britain.
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