Spectrum confirms FDA approves Beleodaq, updates on PMRs for Beleodaq, Folotyn

theflyonthewall.com

Spectrum Pharmaceuticals confirmed in a filing that it received notification from the FDA of their early action granting accelerated approval of the company’s New Drug Application for Beleodaq for Injection for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication was approved by FDA 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. The company also disclosed that on July 3 it received further notifications from the FDA regarding the post marketing requirements, or PMRs, for each of Beleodaq and Folotyn. With respect to Folotyn, the two previous Folotyn PMRs for the Phase 3 PTCL trial and the Phase 3 cutaneous T-cell lymphoma trial have been released by FDA. The new PMRs for Beleodaq and Folotyn include a main study that evaluates the comparative efficacy and safety of Folotyn when used in combination with the treatment regimen cyclophosphamide/ vincristine/doxorubicin/prednisone or the combination of Beleodaq plus CHOP, versus CHOP alone for the initial therapy of patients with PTCL. As previously announced, in 2010 the company licensed the oncology drug asset Beleodaq for Injection from TopoTarget A/S through a license and collaboration agreement for all uses in North America and India, with an option for China. In connection with the transaction, TopoTarget remained eligible to receive contingent consideration upon the achievement of certain regulatory and sales milestones. As a result of the satisfaction of a NDA approval milestone, described above, pursuant to the agreement, the company becomes obligated to pay TopoTarget $25M in cash.

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