FDA approves Beleodaq for T-Cell Lymphoma-BioAlliance Pharma
The FDA has granted Topotarget Accelerated Approval of Beleodaq (belinostat), from BioAlliance Pharma, 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. 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. This study met its primary endpoint: to reach an objective response rate (ORR) of at least 20%.
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