Gilead Sciences announced that a New Drug Application (NDA) has been submitted to the FDA for idelalisib, an investigational, targeted, oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, for the treatment of indolent non-Hodgkin’s lymphoma (iNHL). 

Gilead’s NDA submission for idelalisib is supported by data from a single-arm, open-label Phase 2 efficacy and safety study (Study 101-09) of 125 patients with iNHL refractory to rituximab and to alkylating-agent-containing-chemotherapy. All patients received idelalisib 150mg twice daily and were allowed to continue daily dosing as long as they benefited from therapy. The primary endpoint of the study was overall response rate, defined as the proportion of patients achieving a confirmed complete or partial response with idelalisib treatment. 

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Idelalisib achieved an overall response rate of 53.6% with a median duration of response of 11.9 months. Median progression-free survival for all patients was 11.4 months. Eighty nine percent of patients experienced lymph node shrinkage.

Gilead’s clinical development program for idelalisib includes two Phase 3 studies of idelalisib in combination with approved therapies for previously treated iNHL patients and three Phase 3 studies evaluating idelalisib in combination with approved therapies for patients with previously treated chronic lymphocytic leukemia (CLL).

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