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July 7, 2014
07:02 EDTSPPISpectrum granted accelerated approval for Beleodaq from FDA
Spectrum Pharmaceuticals announced that the U.S. Food and Drug Administration has granted accelerated approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq was approved by the FDA on July 3. This indication was approved based on data from the multi-center, single-arm BELIEF trial in 120 evaluable patients, refractory to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity. A review of data from a planned confirmatory Phase III trial of Beleodaq in combination with CHOP to characterize the efficacy and safety of the Beleodaq combination versus CHOP alone, is required by FDA to convert this accelerated approval to a full approval.
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March 30, 2015
07:04 EDTSPPISpectrum presents new data on Evomela
Spectrum Pharmaceuticals announced results of a clinical study of the stability of Captisol-enabled Melphalan versus the currently marketed, propylene glycol-containing melphalan formulation entitled, Solution Stability of Captisol-enabled Melphalan vs Marketed Melphalan Products. These results were presented in an oral presentation at the annual American Pharmacists Association Annual Meeting & Exposition in San Diego, California.“The improved stability of EVOMELA may potentially ensure that cancer patients receive the full, intended therapeutic dose of intravenous melphalan, by increasing the use time and infusion time, and simplifying clinical administration logistics,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “EVOMELA is a new injectable formulation of melphalan that incorporates the Captisol brand of modified β-cyclodextrin improving the solubility and stability of melphalan. It also uses a standard aqueous diluent for reconstitution, instead of propylene glycol, which is associated with toxicities including renal dysfunction and arrhythmias. We look forward to launching EVOMELA with our existing sales force later this year and providing this new treatment option to cancer patients.”

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