Merck Receives Positive CHMP Opinion for Keytruda for the Treatment of Advanced Melanoma

Merck (MSD uutside the US and Canada) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for Keytruda, which is based on data in more than 1500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union (EU).

“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,” said Roger Dansey, therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories. “We have established a broad data set for Keytruda in the treatment of advanced melanoma, and have demonstrated improvements in progression free survival compared to chemotherapy and a survival benefit compared to ipilimumab. We look forward to working with European health authorities to make Keytruda available to patients.”

Pembrolizumab, which will be marketed under the worldwide brand name of Keytruda, is one of the first of a new generation of immunotherapies that works by blocking the PD-1 pathway. Keytruda was the first anti-PD-1 therapy approved in the US and the first medicine to be accepted under the UK’s Early Access to Medicines Scheme (EAMS), which was introduced to help patients benefit from promising, innovative treatments before a European license has been granted.