Merck Sharp and Dohme receives CHMP backing for EU Keytruda approval

Merck Sharp and Dohme has announced that its new melanoma therapy Keytruda has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency have adopted a positive opinion on the use of the anti-PD-1 therapy for the treatment of advanced melanoma, as both a first-line therapy and in previously treated patients.

This recommendation was based on clinical trial data collated from more than 1,500 patients, which demonstrated the overall survival, progression-free survival and overall response rate benefits the drug can provide.

Roger Dansey, therapeutic area head and senior vice-president for oncology late-stage development at Merck Research Laboratories, said: "Merck is committed to bringing Keytruda to people with advanced melanoma in Europe as rapidly as possible, and the positive CHMP opinion marks a significant step forward."

Keytruda was the first anti-PD-1 therapy approved in the US and is also the first medicine to be accepted under the UK's Early Access to Medicines Scheme (EAMS), introduced to help patients gain access to new treatments before a European license has been granted.