Spectrum Says FDA Decision Likely in 2014; NDA Filing by Mid 2013 for Belinostat

Spectrum Pharmaceuticals, Inc.

, 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.