Merck & Co. Inc. reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion will now be reviewed by the European Commission for central marketing authorization in the European Union (EU).

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.

Keytruda was approved in the United States in 2014 as a treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Merck has a broad linical development program for Keytruda with more than 85 clinical trials, across more than 30 tumor types and over 14,000 patients, both as a monotherapy and in combination with other therapies.

Source: Merck & Co. Inc.