13 April 2016 - Merck today announced that the U.S. FDA has accepted for review the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.

The application is seeking approval for Keytruda as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted priority review with a PDUFA goal date of Aug. 9; the sBLA will be reviewed under the FDA’s accelerated approval program.

For more details, go to: http://www.mercknewsroom.com/news-release/oncology-newsroom/fda-accepts-supplemental-biologics-license-application-sbla-keytrud-2