FDA accepts filing of Beleodaq for T Cell Lymphoma- Spectrum Pharma
Spectrum Pharmaceuticals has announced that its New Drug Application (NDA) for Beleodaq (belinostat), a novel, pan-histone deacetylase (HDAC) inhibitor, has been accepted for filing by the FDA. The FDA establishes review classification for this application as Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 9, 2014. Spectrum is seeking FDA approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).
The filing is for Accelerated Approval.
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