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News Breaks
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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August 21, 2014
10:02 EDTSPPISpectrum weakness attributed to FDA comment on Fusilev generics
The move lower in shares of Spectrum is being attributed to circulation of a Department of Health and Human Services document which states the FDA will be able to approve abbreviated new drug applications for levoleucovorin calcium, the trade name of Spectrum's Fusilev. Shares of Spectrum are down 4%, or 33c, to $7.42. Reference Link

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