ARTICLE | Company News

FDA to review Gilead's idelalisib for NHL

January 14, 2014 2:02 AM UTC

Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted for review an NDA for idelalisib to treat refractory indolent non-Hodgkin's lymphoma (NHL). The PDUFA date is Sept. 11. Gilead also said it submitted an NDA to FDA early last month for the product to treat chronic lymphocytic leukemia (CLL). The small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta has breakthrough therapy designation to treat relapsed CLL. An MAA is under accelerated assessment by EMA for both indolent NHL and CLL. An accelerated assessment shortens the review period to 150 days from 210. ...