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news.The European Commission (EC) has approved Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), to treat advanced (unresectable or metastatic) melanoma in adults.
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The approval is based on data from three clinical studies including Phase Ib KEYNOTE-001 trial, Phase II KEYNOTE-002 trial and Phase III KEYNOTE-006 trial conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma.
The trials evaluated the efficacy and safety of Keytruda in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2mg/kg every three weeks as the approved dose.
The data showed that Keytruda is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma.
Merck Research Laboratories president Dr Roger Perlmutter said: "Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world.
"We believe that the broad data set supporting this approval helps illustrate the significant potential of Keytruda to treat advanced melanoma, a devastating disease."
The approval also allows marketing of Keytruda in all 28 EU member states at the approved dose of 2mg/kg every three weeks.
Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.