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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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November 20, 2015
07:02 EDTSPPISpectrum submits IND to FDA to initiate Phase 2 breast cancer study
Spectrum Pharmaceuticals announced today the company has submitted an IND application to the U.S. Food and Drug Administration and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible. The Phase 2 study is planned to be an open-label study that will enroll approximately 70 patients with HER-2 positive metastatic breast cancer, who have failed at least one or more HER-2 directed therapy. The dose and schedule of oral poziotinib will be based on clinical experience from the studies in Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of HER2-directed therapies.
November 18, 2015
05:35 EDTSPPISpectrum divests rights to Zevalin in Japan, other countries
Spectrum Pharmaceuticals announced the divestment of Zevalin rights in Japan and other countries in Asia Pacific, Middle East, Africa and Latin America, to Mundipharma. Spectrum will receive an up-front payment of $15M plus $5M in profits on initial Zevalin supply. Spectrum will continue to own Zevalin rights for U.S., Canada, and Europe.

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