Merck known as MSD outside the United States and Canada, today 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 KEYTRUDA is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. KEYTRUDA received European Commission regulatory approval based on Phase 3 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. Today’s approval allows marketing of KEYTRUDA in all 28 EU member states at the approved dose of 2 mg/kg every three weeks.
The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of KEYTRUDA in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades. In Europe, approximately 100,000 new cases were estimated to be diagnosed in 2012, which is almost half of the global incidence of melanoma. The five-year survival rates for advanced or metastatic melanoma (Stage IV) are estimated to be 15 to 20 percent in the United States and 5 to 22 percent in Europe.
KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
