Posted by Michael Wonder on 22 Jul 2017
European Medicines Agency’s CHMP recommends approval for Merck’s Keytruda (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
21 July 2017 - Positive opinion is based on overall survival benefit demonstrated in the Phase 3 KEYNOTE-045 Trial and durable responses observed in the Phase 2 KEYNOTE-052 Trial.
Merck announced today that the CHMP of the EMA has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
Specifically, Keytruda is recommended for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who are not eligible for cisplatin-containing chemotherapy. The recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union. A final decision is expected in the third quarter of 2017.
