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Spectrum Pharmaceuticals Submits NDA for Belinostat to FDA

Spectrum Pharmaceuticals (Nasdaq: SPPI) 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

See full press release

Posted-In: News Guidance FDA Management Global

 

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