ARTICLE | Clinical News
FDA accepts Zelboraf sNDA for rare blood disease
August 28, 2017 11:08 PM UTC
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...
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