Merck & Co.’s Anti-PD-1 Antibody Pembrolizumab Accepted for EU ReviewBy
Merck & Co. reports that the European Medicines Agency (EMA) has accepted for review a marketing authorization application for pembrolizumab (MK-3475), the company's investigational anti-PD-1 antibody, for the treatment of advanced melanoma. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.
The biologics license application for pembrolizumab is under priority review with the US Food and Drug Administration for the treatment of patients with advanced melanoma previously-treated with ipilimumab; the Prescription Drug User Fee Act (PDUFA) date is October 28, 2014. Pembrolizumab has been granted FDA's Breakthrough Therapy designation for advanced melanoma.
Pembrolizumab is an investigational, selective, humanized, monoclonal anti-PD-1 antibody designed to reactivate anti-tumor immunity. Pembrolizumab exerts dual ligand blockade of the PD-1 pathway by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2. Pembrolizumab is being evaluated across more than 30 types of cancers as both a monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide.
Source: Merck & Co.