1 December 2016 - Merck today announced that the U.S. FDA has accepted for review the supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin's lymphoma or for patients who have relapsed after three or more prior lines of therapy. 

The FDA granted priority review with a PDUFA, or target action, date of 15 March 2017. The application will be reviewed under the FDA’s accelerated approval program. In April 2016, Keytruda was granted breakthrough therapy designation by the FDA for this indication.

The application is seeking approval for Keytruda at a fixed dose of 200 mg administered intravenously every three weeks and is based on data from the KEYNOTE-087 and KEYNOTE-013 trials, which studied patients with refractory cHL or who had relapsed after three or more prior lines of therapy. 

This is the first application for regulatory approval of Keytruda in a haematologic malignancy.

Read Merck press release