The approval follows a priority review of the Beleodaq new drug application (NDA) and was an Early Approval action prior to the 09 August 2014 PDUFA (Prescription Drug User Fee Act) date.
The drug 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 trial, which enrolled 129 PTCL patients refractory to or who had failed at least one prior systemic therapy.
BioAlliance Pharma CEO Judith Greciet said, "With the FDA’s Accelerated Approval of Beleodaq, the teams of Topotarget have succeeded in developing a new efficacious treatment option for patients with PTCL. Such a key achievement is a very positive sign to begin Onxeo’s long and successful story and it reinforces the value of Onxeo."
The company said that a milestone cash payment of $25m from Spectrum Pharmaceuticals is triggered by the NDA approval.
Beleodaq is a pan HDAC inhibitor in late stage clinical development with over 1,000 patients treated to date.
BioAlliance and Topotarget are merging to develop Onxeo, following approval of shareholders of both companies end of June 2014.
Danish biopharmaceutical firm Topotarget is dedicated to clinical development and registration of oncology products.
In collaboration with Spectrum, Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy.
Image: FDA approval of Beleodaq is based on results from the BELIEF trial, which enrolled 129 PTCL patients. Photo: courtesy of foto76