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Breakthrough Therapy Approved for Leukemia and Lymphoma

By Staff



8/20/2014

US Pharm. 2014;39(8):53.

Silver Spring, MD—The FDA has granted approval for the kinase inhibitor idelalisib (Zydelig) in the treatment of chronic lymphocytic leukemia (CLL) and two types of lymphoma in patients who have relapsed after previous treatment. The approval in relapsed CLL is specifically for use in combination with rituximab (Rituxan) in patients for whom rituximab alone would be considered appropriate therapy because of other comorbidities. The FDA also granted accelerated approval for use in relapsed follicular B-cell non-Hodgkin’s lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). Idelalisib is the fifth new drug with a breakthrough therapy designation to be approved by the FDA, and it is also the third drug with this designation approved to treat CLL.

To comment on this article, contact rdavidson@uspharmacist.com.

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