Gilead Sciences files idelalisib at FDA for NHL

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA 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.

Gilead�s NDA for idelalisib is supported by data from a single-arm, open-label Phase II study (Study 101-09) of 125 patients with iNHL refractory to rituximab and to alkylating-agent-containing chemotherapy. In an interim data analysis single-agent 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. 89 percent of patients experienced lymph node shrinkage.