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Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today provided an update regarding anticipated milestones for the analysis of data and potential regulatory filing related to the pivotal, registrational BELIEF trial of belinostat, a novel histone deacetylase (HDAC) inhibitor. On September 21, 2012, Topotarget A/S, Spectrum’s collaboration partner for the joint development of belinostat, reported preliminary clinical results for the BELIEF trial, which is evaluating the efficacy and safety of belinostat for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). Spectrum is continuing to collect and analyze the data from the trial, and database lock is expected to occur in November/December 2012, following which a definitive determination of the primary endpoint of overall response rate (ORR) will be calculated.
“We are very pleased with the ongoing data collection and its analysis from the BELIEF trial and look forward to a required meeting with the FDA once a definitive ORR has been determined," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Pending final data analysis and agreement with the FDA, we anticipate filing of an NDA application by mid-2013, and FDA decision is likely in 2014.”
About Peripheral T-Cell Lymphoma
According to the Lymphoma Research Foundation (
www.lymphoma.org), lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin's lymphoma and non-Hodgkin's lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally where they typically reside in the lymph glands. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). Peripheral T-cell lymphoma (PTCL) comprises a group of rare and aggressive NHLs that develop from mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL cases in the United States, and projections for annual cancer incidences point to 15,500 new cases of PTCL in the U.S., Japan, and five of the largest EU countries.
FOLOTYN® (pralatrexate injection), the first therapeutic approved for the treatment of PTCL, is marketed by Spectrum pursuant to the Company’s recent acquisition of Allos Therapeutics, Inc.