Gilead's idelalisib gets standard FDA review
This article was originally published in Scrip
Executive Summary
The FDA has granted a standard review to Gilead Sciences’ new drug application (NDA) to market idelalisib, a targeted oral phosphoinositide 3-kinase delta inhibitors, as a treatment for refractory indolent non-Hodgkin's lymphoma (iNHL), a group of largely incurable slow-growing lymphomas that run a relapsing course after therapy and lead ultimately to life-threatening complications, such as serious infections and marrow failure.