Spectrum Pharma Gets FDA's Accelerated Approval For T-Cell Cancer Drug Beleodaq

(RTTNews) - Spectrum Pharmaceuticals Inc. (SPPI) Monday said that the U.S. Food and Drug Administration or FDA has granted accelerated approval for its T-cell lymphoma drug Beleodaq. The approval was based on Tumor Response Rate and Duration of Response. However, an improvement in survival or disease-related symptoms has not been reported. Beleodaq, a histone deacetylase inhibitor, is used for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. It is expected to be available to patients in less than 3 weeks.

This indication was approved based on data from the multi-center, single-arm BELIEF trial in 120 evaluable patients, refractory to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity. For converting this accelerated approval to a full approval, the FDA has to review data from Phase III trial of Beleodaq in combination with CHOP, which will help in evaluating its efficacy and safety.