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FDA Accepts New Drug Application for Idelalisib in Refractory Indolent Non-Hodgkin Lymphoma

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The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K-delta, for the treatment of refractory indolent non-Hodgkin lymphoma (NHL). The FDA has granted a standard review for the NDA, with a target review date of September 11, 2014.

The application was supported by a single-arm phase II study (Study 101-09) evaluating idelalisib in patients with indolent NHL that is refractory to rituximab (Rituxan) and to alkylating agent–containing chemotherapy. Following the NDA submission for indolent NHL, the FDA granted idelalisib a Breakthrough Therapy designation for relapsed chronic lymphocytic leukemia (CLL). An NDA for idelalisib for the treatment of CLL was submitted in December 2013.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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