FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Signs Off on Merck’s Keytruda

Dec. 27, 2018

The European Commission approved Merck’s cancer drug Keytruda (pembrolizumab) for treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.

The EC based the approval on Phase 3 trial data that found it reduced the risk of disease recurrence or death by 44 percent compared to placebos.

The approval clears Keytruda for marketing in all 28 EU member states as well as Iceland, Lichtenstein and Norway. The drug is also approved in Europe as a monotherapy for advanced melanoma in adults.

View today's stories