FDA approved Spectrum Pharmaceutical’s Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare type of non-Hodgkin lymphoma. The action was taken under the agency’s accelerated approval program.
Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment or did not respond to previous treatment. FDA granted accelerated approval to Folotyn (pralatrexate) in 2009 for use in patients with relapsed or refractory PTCL and Istodax (romidepsin) in 2011 for the treatment of PTCL in patients who received at least one prior therapy.
The safety and effectiveness of Beleodaq was evaluated in a clinical study involving 129 participants with relapsed or refractory PTCL. All participants were treated with Beleodaq until their disease progressed or side effects became unacceptable. Results showed 25.8% of participants had their cancer disappear or shrink after treatment.The most common side effects seen in Beleodaq-treated participants were nausea, fatigue, fever, low red blood cells, and vomiting.
Beleodaq and Folotyn are marketed by Spectrum Pharmaceuticals, based in Henderson, Nevada. Istodax is marketed by Celgene Corporation based in Summit, New Jersey.