FDA accepts Zelboraf sNDA for rare blood disease

FDA accepted and granted Priority Review to an sNDA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Zelboraf vemurafenib to treat BRAF V600-positive Erdheim-Chester disease. Its PDUFA date is Dec. 7.

FDA also granted the product breakthrough therapy designation for the indication. Erdheim-Chester disease is a rare blood disease characterized by abnormal multiplication of white blood cells called histiocytes...