Merck & Co. has announced that pembrolizumab is the first drug to be accepted into the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS). This scheme allows patient access to a treatment before the product has received E.U. approval if there is significant unmet medical need. The MHRA assesses the benefits and risks of the drug based on the data available when the EAMS request is submitted. This opinion is valid for a year and can then be renewed.
The programmed cell death protein 1 (PD-1) ligand pembrolizumab received accelerated approval in the U.S. as Keytrudain September 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following treatment with ipilimumab and, if the tumor is positive for the BRAF V600 mutation, treatment with a B-raf inhibitor. It is currently under review at the EMA for advanced melanoma (Merck & Co. News Release).