Pembrolizumab to be first treatment accepted under UK's new Early Access to Medicines Scheme
An announcement has been made by Merck that its anti-PD-1 therapy, pembrolizumab is the first treatment to be approved under the UK's new Early Access to Medicines Scheme (EAMS).
It has been informed that Merck is known as MSD outside the US and Canada. According to Merck, its anti-PD-1 therapy, pembrolizumab is marketed in the United States under the name KEYTRUDA. According to experts, pembrolizumab received acceptance under the scheme for the treatment of advanced melanoma that was based on the importance of the early study results and unmet medical requirement.
On October 10, 2014, Pembrolizumab got the Promising Innovative Medicine (PIM) designation in the UK. Last year, the EAMS has been introduced by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) with an aim to help patients benefit from promising, innovative treatments before a European license has been given.
Dr. Roger Perlmutter, president, Merck Research Laboratories, said that Merck has planned to speed up the development of pembrolizumab and also working together with governments around the world in order to bring our anti-PD-1 therapy to cancer patients.
Perlmutter also said that the acceptance of pembrolizumab into the scheme is going to allow various patients in the UK with advanced melanoma to get earlier access to pembrolizumab. It also highlights the significance of making new mechanisms in order to bring promising medicines to patients who have restricted options.
One of the first of a new generation of immuno-oncology therapies called anti-PD-1s is pembrolizumab. Earlier, Pembrolizumab received Breakthrough Therapy Designation for advanced melanoma by the US Food and Drug Administration(FDA) and it received approval in September last year.
Gillian Nuttall, Melanoma UK, said that this news is going to be greatly received by the melanoma community in the U.K. “At the moment, there are limited options for advanced melanoma patients, the majority of whom are in difficult positions which simply means they cannot afford to play any kind of waiting game”, added Nuttall.