Merck & Co immunotherapy Keytruda gets EU okay for melanoma

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Merck & Co’s anti-PD-1 therapy Keytruda has been given the green light in Europe for the treatment of advanced skin cancer.

The European Commission has approved Keytruda (pembrolizumab) for advanced melanoma in adults after the immunotherapy showed superior survival benefit as a monotherapy compared to Bristol-Myers Squibb’s Yervoy (ipilimumab), the current standard of care. One-year survival was 74% versus 58% for Yervoy, while the risk of death was cut by 37%.

The approval allows marketing of Keytruda in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. Roger Perlmutter, president of Merck Research Laboratories, said the green light in Europe “supports our goal of accelerating immuno-oncology research for the benefit of patients around the world”.

Keytruda will go up against B-MS’ Opdivo (nivolumab), the first PD-1 inhibitor to get European approval for melanoma when it got the thumbs-up last month.