Beleodaq gains FDA approval for treatment of peripheral T-cell lymphoma

The US FDA has approved Beleodaq™ (Spectrum Pharmaceuticals, Inc., NV ,USA [belinostat]) for the treatment of patients with peripheral T-cell lymphoma (PTCL), including non-Hodgkin lymphoma. PTCL comprises a group of rare diseases in which lymph nodes become cancerous. The National Cancer Institute estimates that in 2014 70,800 Americans will be diagnosed with non-Hodgkin lymphoma and 18,990 will die from the disease.

Beleodaq works by preventing the action of enzymes that contribute to T-cells becoming cancerous. The agent is intended for the treatment of patients whose disease has relapsed or did not respond to previous treatment.

Richard Pazdur (Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research) commented, “This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma. Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”

In 2009 the FDA granted accelerated approval to Folotyn (pralatrexate) for use in patients with relapsed or refractory PTCL and in 2011 they approved Istodax (romidepsin) for the treatment of PTCL in patients who had received at least one prior therapy.

A study involving 129 participants with relapsed or refractory PTCL was used to evaluate the safety and effectiveness of Beleodaq. All participants were treated with Beleodaq until their disease progressed or until they could no longer tolerate the side effects. The researchers reported that 25.8% of participants had their cancer disappear or shrink after treatment.

Common side effects seen in Beleodaq-treated participants were nausea, fatigue, fever (pyrexia), low red blood cells (anemia), and vomiting.

As with all drugs receiving accelerated approval, Beloleodaq is subject to confirmatory trials verifying clinical benefit. Beleodaq also received orphan product designation by the FDA because it is intended to treat a rare disease or condition.

Source: FDA press release