Roche: FDA grants priority review to Zelboraf.
(CercleFinance.com) - Roche's Genentech said on Monday that the US Food and Drug Administration (FDA) has granted priority review to Zelboraf for the treatment of Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Zelboraf had been granted breakthrough therapy designation (BTD) by the FDA.
The FDA is now expected to make a decision on approval by December 2017.
Erdheim-Chester disease is a rare blood disease that is characterised by the abnormal multiplication of certain white blood cells called histiocytes.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
Zelboraf had been granted breakthrough therapy designation (BTD) by the FDA.
The FDA is now expected to make a decision on approval by December 2017.
Erdheim-Chester disease is a rare blood disease that is characterised by the abnormal multiplication of certain white blood cells called histiocytes.
Copyright (c) 2017 CercleFinance.com. All rights reserved.