By: IPP Bureau
Last updated : November 16, 2024 5:07 pm
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
Merck, known as MSD outside of the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).
“The CHMP’s positive opinion marks an important milestone for patients in Europe with non-epithelioid mesothelioma, who experience worse survival outcomes than patients with epithelioid mesothelioma,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories.
“The positive CHMP opinion moves us closer to offering a new first-line treatment option with a proven overall survival benefit for certain patients in the European Union with this difficult-to-treat cancer.”