Posted by Michael Wonder on 31 Mar 2021
Merck receives positive EU CHMP opinion for updated label of Keytruda (pembrolizumab) to include results of Phase 3 KEYNOTE-361 trial in certain adult patients with locally advanced or metastatic urothelial cancer
30 March 2021 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending that the European label for Keytruda, Merck’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.
In Europe, Keytruda is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a Combined Positive Score (CPS) ≥10.
This approval was based on a single-arm study, KEYNOTE-052; KEYNOTE-361 was conducted as part of a post-marketing commitment following the initial approval of Keytruda for these patients.
