Gilead Sciences announced that the FDA has accepted for review its New Drug Application (NDA) for idelalisib, a targeted oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin’s lymphoma (iNHL).
The NDA submission was supported by a single arm Phase 2 study (Study 101-09) evaluating idelalisib in patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.
Idelalisib is an investigational, highly selective, oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, which is hyperactive in many B-cell malignancies. Inhibition of this kinase blocks the activation, proliferation, survival, and trafficking of B lymphocytes.
Previously the FDA had granted idelalisib a Breakthrough Therapy designation for relapsed chronic lymphocytic leukemia (CLL).
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