BioAlliance Pharma SA said Thursday the U.S. Food and Drug Administration has granted Denmark-based Topotarget, accelerated approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).
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.
A milestone cash payment of $25 million from Spectrum Pharmaceuticals is triggered by the drug's approval. A double-digit royalties as well as sales milestones of the aggregated net sales will be received by the company.
BioAlliance Pharma and Topotarget are merging to create Onxeo, following approval of shareholders of both companies end of June 2014.
Topotarget is a biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals Inc, 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.
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