FDA Accepts Gilead's NDA for Idelalisib Against Indolent Lymphomas

According to Gilead Sciences, a biopharmaceutical company in the business of innovative therapeutics based in the San Francisco Bay area, the US Food and Drug Administration has accepted for review the company's New Drug Application (NDA) for idelalisib.

Idelalisib is an investigational, highly selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta. PI3K delta signaling is critical for the activation, proliferation, survival and trafficking of B lymphocytes and is hyperactive in many B-cell malignancies.

The current NDA is for the treatment of refractory indolent non-Hodgkin's lymphoma (iNHL).

Gilead submitted the NDA on Sept. 11, 2013. Since the FDA granted standard review, it has set a target review date under the Prescription Drug User Fee Act (PDUFA) of Sept. 11, 2014.

Gilead's NDA for iNHL is supported by a single arm Phase II study evaluating idelalisib in patients with iNHL that is considered refractory to rituximab and to alkylating-agent-containing chemotherapy.

The FDA previously granted idelalisib a Breakthrough Therapy designation for relapsed chronic lymphocytic leukemia (CLL), and Gilead previously submitted an NDA for the same drug back in December of 2013 for CLL treatment.

Source: Gilead

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