Posted by Michael Wonder on 15 Mar 2017
Merck provides update on supplemental biologics license application for Keytruda (pembrolizumab) in previously treated advanced microsatellite instability-high cancer
14 March 2017 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high cancer.
The company recently submitted additional data and analyses to the FDA related to the pending application. The submission of additional data is considered a major amendment to the application under the Prescription Drug User Fee Act, thus extending the target action date by three months. The new FDA target action date is 9 June 2017.
Merck continues to work closely with the FDA to support the review of this sBLA and looks forward to further advancing the science of immuno-oncology in microsatellite instability-high cancer.
