13 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Gilead Sciences has submitted a new drug application (NDA) to the US FDA for the approval of Idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin's lymphoma (iNHL).
Based on the rate and duration of response observed until date, in a highly refractory iNHL patient population, teh firm believes that Idelalisib could become an important new therapy for patients who have limited treatment options.
Indolent non-Hodgkin's lymphoma refers to 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.
Most iNHL patients are diagnosed at an advanced stage of disease, and median survival from time of initial diagnosis for patients with the most common form of iNHL, follicular lymphoma, is eight to 10 years. The outlook for refractory iNHL patients is significantly poorer.
"Gilead is committed to advancing a pipeline of novel cancer therapies that have the potential to improve the lives of patients," said Dr John C Martin, chairman and CEO, Gilead Sciences.