CHMP Favors EU Approval of Keytruda for Advanced Melanoma Patients with Complete Tumor Resection

Source: Immuno-oncology News, December 2018

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Keytruda(pembrolizumab) for the treatment of advanced melanoma patients whose tumor has been completely removed in surgery.

The European Commission will now review CHMP’s opinion before making a final decision regarding approval, which is expected by year’s end.

“There is a growing need for innovative therapies that can help reduce the risk of recurrence following surgery in patients with stage III melanoma,” Scot Ebbinghaus, MD, vice president of clinical research for Merck Research Laboratories, said in a press release. “Today’s news reflects the collaborative efforts of Merck and the European Organisation for Research and Treatment of Cancer (EORTC) to improve the way we treat melanoma earlier in the treatment paradigm.