EU approves Keytruda (pembrolizumab) for advanced melanoma- Merck

Merck Inc announced that the European Commission has approved Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults. The European Commission 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 can provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. The safety analysis supporting the European approval of pembrolizumab was based on 1,012 advanced melanoma patients across three doses (2 mg/kg every three weeks or 10 mg/kg every two or three weeks) in studies KEYNOTE-001 and KEYNOTE-002 combined. The most common adverse reactions (>10%) with pembrolizumab were diarrhoea (15%), nausea (12%), pruritus (25%), rash (25%), arthralgia (13%) and fatigue (33%).

The approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks.