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FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq (belinostat) for Injection

Monday, 7 Jul 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of Beleodaq for treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response.Says an improvement in survival or disease-related symptoms has not been established.Says Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.Says In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity.PTCL comprises a group of rare and aggressive non-Hodgkin's Lymphomas (NHL) that develop from mature T-cells and accounts for about 10 to 15 pct of all NHL cases in the United States.These patients generally have a poor prognosis with a low response rate (25-27 pct) to available treatment options, and commonly experience repeated treatment failures until drug resistance or death.Therefore, there has been an important unmet medical need for these patients with PTCL for additional new treatment options that are specifically effective for this disease. 

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17 Apr 2015