Merck (MRK) 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.
The FDA has set a PDUFA, or target action, date of June 28, 2018. The application, which is seeking accelerated approval for the new indication, is based in part on data from the phase 2 KEYNOTE-158 trial.
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