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December 10, 2013
07:04 EDTSPPISpectrum announces Belinostat New Drug Application submission
Spectrum announced the that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of Belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Response from the FDA regarding acceptance to file is expected within 60 days from the FDA receipt date. Over 1K patients have been exposed to belinostat across the development program that included 14 Sponsor-initiated studies and 16 additional NCI or investigator sponsored studies in various indications. The company said, "Based on the clinical data, belinostat was shown to have an acceptable safety profile and clinical efficacy, with complete responses in heavily pretreated patients. In June, data was presented which demonstrated the clinical activity of belinostat in treating patients 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.
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