Gilead Sciences Submits New-drug Application For Idelalisib - Quick Facts

(RTTNews) - Gilead Sciences, Inc. (GILD) Wednesday said it has filed a New Drug Application, or NDA, with the U.S. Food and Drug Administration for approval of idelalisib, an investigational drug indicated for the treatment of indolent non-Hodgkin's lymphoma.

Indolent non-Hodgkin's lymphoma is a group of slow-growing lymphomas that run a relapsing course after therapy, leading to life-threatening complications such as serious infections and marrow failure. Diagnosed at an advanced stage, the median survival range for an iNHL patient is said to be 8 to 10 years.

"Based on the rate and duration of response observed to date in this highly refractory iNHL patient population, we believe idelalisib could become an important new therapy for patients who have limited treatment options, " said John Martin, Chairman, CEO.

Gilead's NDA for idelalisib is backed by data from Phase 2 study of 125 patients, wherein idelalisib achieved an overall response rate of 53.6 percent, with a median duration of response of 11.9 months. Median progression-free survival for all patients was 11.4 months.

Gilead is also planning to file for regulatory approval of idelalisib in the European Union in the fourth quarter of this year.