Shares of Spectrum Pharmaceuticals (NASDAQ: SPPI) gained 5.7 percent following the U.S. Food and Drug Administration's approval of the New Drug Application (NDA) for Beleodaq.
Accelerated Approval for Beleodaq
In an 8-K filing on Wednesday, Spectrum reported that it gained accelerated approval for Beleodaq™ (belinostat) for Injection for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (“PTCL”). This indication was approved by FDA under accelerated approval based on tumor response rate and duration of response.
Additional Notifications from FDA
On Monday, Spectrum Pharmaceuticals received additional information from the FDA on post marketing requirements for Beleodaq and Folotyn.
The Phase 3 PTCL trial and the Phase 3 cutaneous T-cell lymphoma (“CTCL”) trial of Folotyn have been released by the Food and Drug Administration.
The release further stated, "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 (“CHOP”) or the combination of Beleodaq plus CHOP, versus CHOP alone for the initial therapy of patients with PTCL."
Shares of Spectrum Pharmaceuticals closed at $8.72 on Wednesday. The stock jumped as much as 5.7 percent Thursday morning. Shares are currently trading at $9.12, up 4.59 percent.
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