Posted by Michael Wonder on 18 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
18 May 2017 - Keytruda is the only anti-PD-1 therapy to demonstrate superior overall survival versus chemotherapy in patients with advanced urothelial carcinoma post-platinum failure.
Merck today announced that the U.S. FDA has approved two new indications for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
In the first-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
