The European Medicines Agency accepts Merck's (MRK) MAA for pembrolizumab, the firm's investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved, it will be the first anti-PD-1 therapy cleared for sale in Europe.
Pembrolizumab is a humanized monoclonal anti-PD-1 antibody designed to reactivate anti-tumor immunity. It blocks the PD-1 pathway by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2.
It is being evaluated across more than 30 types of cancers as a monotherapy and in combination. The company's BLA is currently under priority review by the FDA with a PDUFA date of October 28, 2014. The agency designated it a Breakthrough Therapy for advanced melanoma.