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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Accepts Spectrum Pharmaceuticals’ Beleodaq NDA

Feb. 7, 2014

The FDA has accepted Spectrum Pharmaceuticals’ NDA for Beleodaq, an injectable treatment for lymphoma, and granted the drug priority review, the Henderson, Nev.-based company said Thursday. The drug has a PDUFA date of Aug. 9.

Beleodaq (belinostat) differs from other HDAC inhibitors in that it inhibits all three classes of zinc-dependent HDAC enzymes: Class I, Class II and Class IV, Spectrum says.

This change leads to different alterations in histone and non-histone protein acetylation that could influence factors such as chromatin accessibility, gene transcription and clinical activity in different cancer patients, including patients with drug-resistant disease.

This is important because approximately 70 percent of these patients fail currently approved treatments; a few patients treated with the drug were even able to go to have stem cell transplants, Spectrum says.

Beleodaq, which is believed to inhibit cell division and angiogenesis and induce cell death and differentiation, is currently being studied in multiple clinical trials as a monotherapy and in combination with chemotherapy drugs to treat hematological and solid tumors, leukemia, myelodysplastic syndrome, reproductive cancers and non-small-cell lung cancer. — Lena Freund

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