EC OKs Merck’s New Cancer Drug Keytruda
The European Commission has approved Merck & Co. Inc.’s Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for treating advanced (unresectable or metastatic) melanoma in adults. The approval allows marketing of Keytruda in all 28 European Union member states at the approved dose of 2 mg/kg every three weeks.
Keytruda 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.
With the European Commission decision, Keytruda is now approved in more than 35 countries for the treatment of advanced melanoma. Merck is advancing a broad clinical development program for Keytruda with more than 100 clinical trials, across more than 30 tumor types and enrolling more than 16,000 patients, both as a monotherapy and in combination with other therapies.
Keytruda was approved in the US in 2014 at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Source: Merck & Co.