FDA Accepts NDA for Gilead's Idelalisib for Treatment of Refractory Indolent Non-Hodgkin's Lymphoma

Gilead Sciences

announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K delta, for the treatment of refractory indolent non-Hodgkin's lymphoma (iNHL). FDA has granted a standard review for the iNHL NDA and has set a target review date under the Prescription Drug User Fee Act (PDUFA) of September 11, 2014.