Spectrum Pharmaceuticals Announces Achievement of Target Enrollment in Registrational Trial for Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Strategic Insights -

Spectrum Pharmaceuticals, a biotechnology company focused on hematology and oncology, has announced that it has achieved the target enrollment of its registrational trial for belinostat, a novel HDAC inhibitor, in relapsed or refractory peripheral T-cell lymphoma (PTCL). The trial, known as the BELIEF registrational study, is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) and has been granted Orphan Drug and Fast Track designations. The trial's primary endpoint is centrally reviewed objective overall response rate (ORR), and the company plans to file a new drug application in 2012.

Key Takeaways:

  • Spectrum Pharmaceuticals has achieved target enrollment in its registrational trial for belinostat in relapsed or refractory PTCL, a rare and aggressive form of non-Hodgkin's lymphoma.
  • The trial, known as the BELIEF registrational study, is being conducted under a Special Protocol Assessment (SPA) with the FDA and has been granted Orphan Drug and Fast Track designations.
  • The trial will evaluate belinostat as a monotherapy treatment for relapsed or refractory PTCL, and its primary endpoint is centrally reviewed objective overall response rate (ORR).
  • Belinostat has been shown to be active as a single agent and in combination with other chemotherapeutic agents in multiple clinical trials, and it has the potential to play an important role in therapy for PTCL and other indications.
  • Spectrum Pharmaceuticals has a strong pipeline of late-stage clinical and commercial products, including belinostat, and it is committed to developing novel treatments for lymphoma and other hematological and solid cancers.

Statistics:

  • PTCL accounts for approximately 10% to 15% of all NHL cases in the United States.
  • The BELIEF registrational study is an open-label, multicenter, single-arm efficacy and safety study in patients with relapsed or refractory PTCL.
  • The primary endpoint of the trial is centrally reviewed objective overall response rate (ORR).

Sources:

  • Spectrum Pharmaceuticals. (2011). Spectrum Pharmaceuticals Announces Achievement of Target Enrollment in Registrational Trial for Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma.
  • Lymphoma Research Foundation. (n.d.). About Lymphoma.
  • U.S. Food and Drug Administration. (n.d.). Fast Track Designation.
  • U.S. Food and Drug Administration. (n.d.). Orphan Drug Designation.
  • National Cancer Institute. (n.d.). Belinostat.