Gilead files for US approval of iNHL drug candidate

US biotech major Gilead Sciences (Nasdaq: GILD), best known for its prowess in antivirals (HIV and hepatitis dugs), yesterday (September 11) revealed that it has submitted a New Drug Application to the US Food and Drug Administration for approval of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin's lymphoma (iNHL).

The data submitted in this NDA support the use of idelalisib for patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy, the company noted.

Gilead acquired rights to idelalisib along with its around $520 million takeover last year of Canada’s YM BioSciences (The Pharma Letter December 13, 2012). Previously, iNHL had been a largely unstudied population for which there is significant unmet medical need for effective therapy. If cleared for marketing, idelalisib would be the first PI3K Delta targeted therapy approved for a hematological cancer and first a new class of therapy cleared for iNHL in more than a decade.