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Spectrum Pharmaceuticals, Inc. (SPPI) Announces Submission Of New Drug Application For Belinostat, A Novel Pan-HDAC inhibitor


12/10/2013 10:05:08 AM

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HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, announced today the that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Belinostat, a pan-histone deacetylase (HDAC) inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). Belinostat is differentiated from other HDAC inhibitors that selectively inhibit a single class of HDAC enzymes by virtue of its inhibition of all 3 classes of the zinc-dependent HDAC enzymes (Class I, Class II and Class IV); this leads to different alterations in histone and non-histone protein acetylation that, in turn, could importantly influence chromatin accessibility, gene transcription, and activity in different cancer patients, including those who develop drug resistant disease.

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