Posted by Michael Wonder on 03 Feb 2017
FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings
3 February 2017 - Keytruda also receives breakthrough therapy designation for second-line treatment based on KEYNOTE-045, which includes primary endpoints of overall survival and progression-free survival.
Merck today announced that the U.S. FDA has accepted for review two supplemental biologics license applications for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. Specifically, the application for first-line use was accepted and granted priority review for the treatment of these patients who are ineligible for cisplatin-containing therapy.
The application for second-line use was also accepted and granted priority review for these patients with disease progression on or after platinum-containing chemotherapy. The PDUFA, or target action, date for both applications is 14 June 2017.
