Merck Sharp and Dohme’s Keytruda receives EU approval

Merck Sharp and Dohme has announced that its new anti-PD-1 therapy Keytruda has been approved in Europe for the treatment of advanced melanoma in adults.

The European Commission approval applies to both first-line and previously-treated patients with advanced melanoma and is based on data from three clinical studies conducted in more than 1,500 individuals.

In these phase III trials, it was shown that Keytruda is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to the current standard of care.

Overall, the Keytruda clinical development programme encompasses more than 100 clinical trials, spanning in excess of 30 tumour types and enrolling more than 16,000 patients.

Dr Roger Perlmutter, president of Merck Research Laboratories, said: "We believe that the broad data set supporting this approval helps illustrate the significant potential of Keytruda to treat advanced melanoma, a devastating disease."

The drug became the first treatment to be accepted under the UK's new Early Access to Medicines Scheme earlier this year.