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Trials & Filings

Gilead iNHL Drug Gets PDUFA Date

Idelalisib has Breakthrough designation for CLL

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Gilead Sciences‘ NDA for idelalisib, a targeted, oral inhibitor of PI3K delta, has been accepted for review by the FDA for the treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL). FDA has granted a standard review for the NDA and has set a target review date under the Prescription Drug User Fee Act (PDUFA) of September 11, 2014.

The NDA, submitted on September 11, 2013, was supported by a single-arm Phase II study evaluating idelalisib in patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy. Following Gilead’s NDA submission for iNHL, FDA granted idelalisib a Breakthrough Therapy designation for relapsed chronic lymphocytic leukemia (CLL). The FDA grants Breakthrough Therapy designation to drug candidates that may offer major advances in treatment over existing options. Gilead submitted an NDA for idelalisib for the treatment of CLL on December 6, 2013.

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