Keytruda gets FDA review in cHL, NICE nod in NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab to treat refractory classical Hodgkin’s lymphoma, or cHL in patients who relapsed after three or more prior lines of therapy. The PDUFA date is March 15, 2017. The mAb against PD-1 has breakthrough therapy designation in the indication, and Merck is seeking the drug's accelerated approval for cHL.

In May, FDA approved rival PD-1 inhibitor Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and treatment with Adcetris brentuximab vedotin from Seattle Genetics Inc. (NASDAQ:SGEN) (see BioCentury Extra, May 17)...