Belinostat filed at FDA for T Cell Lymphoma-Spectrum Pharma

Spectrum Pharmaceuticals announced that the that the company has submitted a New Drug Application (NDA) to the 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.

In June 2013, data was presented at an oral session at ASCO which demonstrated the clinical activity of belinostat in treating patients (N=129) with R/R PTCL with an overall response rate of 26% in these heavily pretreated patients that included patients who had received a previous allogeneic or autologous stem cell transplant.