On July 3, 2014 Topotarget reported that the U.S. Food and Drug Administration (FDA) has granted its partner, Spectrum Pharmaceuticals, Inc., Accelerated Approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) (Press release TopoTarget, JUL 3, 2014, View Source [SID:1234500612]). This follows a Priority Review of the Beleodaq New Drug Application (NDA) and was an Early Approval action prior to the August 9 PDUFA (Prescription Drug User Fee Act) date.

Beleodaq was granted marketing authorization under the FDA’s accelerated approval program, which allows conditional approval of a medicine for a life-threatening disease based on early evidence suggesting clinical benefit. The approval is based on results from the BELIEF study, which enrolled 129 PTCL patients refractory to or who had failed at least one prior systemic therapy.

“With the FDA’s Accelerated Approval of Beleodaq, we have succeeded in developing a new treatment option for patients with PTCL. We are very pleased with the validation of our compound and find that it truly underlines the rationale behind Topotarget’s merger with BioAlliance Pharma in providing an even stronger orphan oncology pipeline for the combined entity, Onxeo”, says Anders Vadsholt, CEO of Topotarget.