KEYTRUDA is First Medicine to be Made Available to Patients Through U.K. EAMS for Advanced Melanoma

Source: Finchannel, March 2015

The FINANCIAL — Merck (NYSE:MRK), known as MSD outside the United States and Canada, on March 10 announced that the company’s anti-PD-1 therapy, pembrolizumab, which is marketed in the U.S. under the name KEYTRUDA, is the first treatment to be accepted under the U.K.’s new Early Access to Medicines Scheme (EAMS).
Pembrolizumab was accepted under the scheme for the treatment of advanced melanoma based on the significance of the early study findings and unmet medical need. Pembrolizumab received the Promising Innovative Medicine (PIM) designation in the U.K., on Oct. 10, 2014, according to Merck.

In 2014, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) introduced the EAMS to help patients benefit from promising, innovative treatments before a European license has been granted. The European Marketing Authorization for pembrolizumab for the treatment of advanced melanoma is currently 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, president, Merck Research Laboratories. “This acceptance of pembrolizumab into the Scheme will enable many patients in the U.K. with advanced melanoma to gain earlier access to pembrolizumab, and underscores the importance of creating new mechanisms to bring promising medicines to patients for whom there are limited options.”

Pembrolizumab is one of the first of a new generation of immuno-oncology therapies called anti-PD-1s (programmed death receptor-1). The EAMS acceptance was based on review of data for pembrolizumab from KEYNOTE-001, the largest Phase 1b study of an anti-PD-1 therapy in patients with advanced melanoma. Pembrolizumab was previously granted Breakthrough Therapy Designation for advanced melanoma by the U.S. Food and Drug Administration based on these data, and approved in September of 2014.

“This news will 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,” said Gillian Nuttall, Melanoma UK. “We welcome early access to this treatment for advanced patients made possible through this new scheme. There is clearly an unmet need and we are delighted such progress is being made.”

“We welcome the Government’s proactive approach in facilitating early access to medicines for critically ill patients and are delighted that pembrolizumab will be the first innovative medicine to be available to patients through the Early Access to Medicines Scheme,” said Mike Nally, managing director for MSD UK and Ireland.

To date, more than 3,500 patients in over 40 countries have received early access to pembrolizumab for the treatment of advanced melanoma through the company’s global expanded access program. Today, Merck is advancing a broad and fast-growing clinical development program for pembrolizumab with more than 70 clinical trials – across more than 30 tumor types and over 8,000 patients – both as a monotherapy and in combination with other therapies.