Merck Sharp and Dohme’s new melanoma drug accepted for EU review

Merck Sharp and Dohme has had a marketing authorisation application for a promising melanoma therapy accepted by the European Medicines Agency.

Pembrolizumab, also known as MK-3475, is the company's investigational anti-PD-1 antibody for the treatment of advanced melanoma. It has already been granted breakthrough therapy designation by the US Food and Drug Administration.

It is being evaluated across more than 30 types of cancers, both as a monotherapy and in combination. By the end of 2014, the pembrolizumab development programme will grow to more than 24 clinical trials, enrolling around 6,000 patients at nearly 300 clinical trial sites worldwide.

If approved by the European Commission, pembrolizumab would become the first anti-PD-1 therapy available in Europe.

Dr Roy Baynes, senior vice-president for clinical development at Merck Research Laboratories, said: "We are pleased to have regulatory applications under review in the US and Europe as we work toward bringing pembrolizumab to patients around the world."

Last month, the company agreed a deal to purchase Idenix Pharmaceuticals, a transaction that will greatly expand its capabilities in the field of hepatitis C research.