Posted by Michael Wonder on 14 Mar 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytuda (pembrolizumab) for treatment of advanced cervical cancer
13 March 2018 - First filing acceptance for an anti-PD-1 therapy in cervical cancer.
Merck today announced that the U.S. FDA has accepted a new supplemental biologics license application and granted Priority Review for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy. The application is seeking approval for Keytruda as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy.
This is the first filing acceptance and priority review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for Keytruda. The FDA has set a PDUFA, or target action, date of 28 June 2018.
