MERCK & Co cancer drug Keytruda was announced yesterday as the first medicine to be made available to patients in Britain under a new early access scheme.
Keytruda works by boosting the immune system and has yet to be licensed in the rest of Europe.
The Medicines and Healthcare Products Regulatory Agency said that the treatment had been cleared to treat adults and children from 12 years of age with advanced melanoma, the deadliest form of skin cancer, after other drugs had failed.
Keytruda, or pembrolizumab, was accepted under the scheme based on the significance of early study findings and unmet medical need. It had already received a “promising innovative medicine” designation in Britain in October 2014.
The British initiative, which has similarities with a US scheme that has accelerated the development of so-called breakthrough medicines, follows criticism that the National Health Service is too slow to adopt new treatments.
While Keytruda is already approved in the United States, Merck’s application for marketing authorisation in Europe is still under review.
“Merck has charted a path to accelerate the development of pembrolizumab, and is collaborating with governments around the world to bring our anti-PD-1 therapy to cancer patients,” said Dr Roger Perlmutter, the president of Merck Research Laboratories.