FDA Advances Genentech's Zelboraf to Treat Rare Blood Disease

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation.

ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes. Zelboraf was also granted Breakthrough Therapy designation (BTD) by the FDA for this indication. The FDA is expected to make a decision on approval by...