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news.Merck has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Keytruda (pembrolizumab), an anti-PD-1 therapy to treat advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients.
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The positive opinion of Keytruda was based on efficacy and safety data in more than 1,500 patients with advanced melanoma in three studies, a large Phase Ib KEYNOTE-001 study; a randomized, controlled study KEYNOTE-002; and an interim analysis from a second, randomized, controlled study, KEYNOTE-006
The European Commission will now review CHMP positive opinion for Keytruda for central marketing authorization in the European Union (EU).
Merck Research Laboratories therapeutic area head and senior vice-president, oncology late stage development Roger Dansey 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.
"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 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).
EAMS was introduced to help patients benefit from promising, new treatments before an European license has been granted.