Merck & Co's Keytruda approved for advanced melanoma in Europe

The European Commission has approved US pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults, in both first-line and previously-treated patients.

The approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase III data which showed it 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. The approval allows marketing of pembrolizumab in all 28 EU member states.

“Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world,” said Roger Perlmutter, president, Merck Research Laboratories, adding: “We believe that the broad data set supporting this approval helps illustrate the significant potential of pembrolizumab to treat advanced melanoma, a devastating disease.”