linostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The approval was done under the agency’s accelerated approval program. PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. PTCL represents approximately 10% to 15% of NHL cases in North America.
Belinostat works by preventing the development of T-cells from becoming cancerous. The drug is approved for use in patients with relapsed or refractory PTCL. According to the FDA, this is the third drug approved since 2009 for this indication.
The safety and effectiveness of belinostat were evaluated in a clinical trial involving 129 patients with relapsed or refractory PTCL. All patients received belinostat until disease progression or until their side effects became unacceptable. The results showed that 25.8% of patients had complete or partial response after treatment.
The most common side effects seen with belinostat were nausea, fatigue, fever, anemia, and vomiting.
Belinostat also received orphan drug designation by the FDA, because it is intended for the treatment of patients with PTCL, which is a rare disease.