WASHINGTON -- The FDA has approved the histone deacetylase inhibitor (Beleodaq) for treatment of peripheral T-cell lymphoma (PTCL), an uncommon but aggressive form of non-Hodgkin lymphoma (NHL).
The approval is for patients with PTCL that has relapsed or proven refractory to previous therapy, according to a statement from the agency.
PTCL comprises a group of malignant conditions that center on the lymph nodes. The disease accounts for 10% to 15% of NHL, a larger group of hematologic cancers that collectively affect about 71,000 Americans each year, according to the National Cancer Institute.
Understanding of belinostat's anticancer activity remains incomplete, but the drug interferes with development of T-cells, which become malignant in the case of PTCL.
FDA based the approval on results of a clinical trial involving 129 patients with relapsed or refractory PTCL. Results showed that 25.8% of the patients attained complete or partial remission with belinostat. The most frequently reported adverse effects associated with treatment were nausea, fatigue, fever, anemia, and vomiting.
Approved as part of the FDA's accelerated approval program, belinostat is the third agent for PTCL to receive approval since 2009, joining (Folotyn) and (Istodax). Beleodaq and pralatrexate are marketed by Spectrum Pharmaceuticals and romidepsin by Celgene.
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