FDA extends action date on Keytruda sBLA

The US Food and Drug Administration has extended the action date for the supplemental Biologics License Application (sBLA) for Keytruda  (pembrolizumab), US pharma giant Merck & Co’s (NYSE: MRK) anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high (MSI-H) 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 sBLA under the Prescription Drug User Fee Act (PDUFA), thus extending the target action date by three months. The new FDA target action date is June 9, 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 MSI-H cancer.