Merck: CHMP Adopts Positive Opinion For Updated Label Of KEYTRUDA To Include Data From KEYNOTE-361

(RTTNews) - Merck (MRK) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that the European label for KEYTRUDA, the company's anti-PD-1 therapy, be updated to include data from KEYNOTE-361, a phase 3, open-label trial that evaluated KEYTRUDA as a monotherapy and in combination with chemotherapy for the first-line treatment of certain patients with advanced or metastatic urothelial carcinoma.

KEYNOTE-361 was conducted as part of a post-marketing commitment following the initial approval of KEYTRUDA. KEYNOTE-361 did not meet its primary endpoints for the combination of KEYTRUDA plus chemotherapy. The CHMP concluded that the benefit-risk profile remains positive and that including data from KEYNOTE-361 in the label allows physicians to evaluate the potential benefit-risk of KEYTRUDA on an individual basis.