Belinostat Approved for Peripheral TCell Lymphoma

The United States Food and Drug Administration (FDA) has approved belinostat (Beleodaq) for the treatment of peripheral T-cell lymphoma. Belinostat was approved under the FDA’s accelerated approval program and is to be used in patients whose disease has recurred, or stopped responding to standard therapies.
Peripheral T-cell lymphoma (PTCL) accounts for approximately 10-15% of non-Hodgkin’s lymphomas diagnosed in the United States. Although most NHLs involve the immune cells called B-cells, PTCL includes several different subgroups of NHL that involve immune cells called T-cells. PTCL tends to be an aggressive type of NHL.

Belinostat is referred to as a histone deacetylase inhibitor. It works by inhibiting targeted biologic processes involved in the growth of cancerous T-cells.

The trial that prompted the approval of belinostat included 129 patients with recurrent or refractory PTCL . All patients were treated with belinostat and nearly 26% achieved a complete or partial disappearance of their cancer.

The most common side effects were nausea, fatigue, fever, low levels of red blood cells and vomiting.

Reference: United States Food and Drug Administration. FDA News Release: FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin’s lymphoma. Available at: Accessed July 5, 2014.