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FDA Approves Beleodaq (Belinostat) to Treat Rare Type of Non-Hodgkin Lymphoma

Therapy helps patients with peripheral T-cell disease

The FDA has approved Beleodaq (belinostat, 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 action was taken under the agency’s accelerated approval program.

PTCL consists of a diverse group of rare diseases in which lymph nodes become cancerous. The National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL in 2014 and that 18,990 will die of the disease. PTCL represents approximately 10% to 15% of NHLs in North America.

Belinostat works by stopping enzymes that contribute to the development of cancer in T-cells, a type of immune cell. The drug is intended for patients with relapsed or refractory PTCL.

Belinostat is the third treatment approved by the FDA for patients with PTCL. The agency granted accelerated approval to Folotyn (pralatrexate, Spectrum Pharmaceuticals) in 2009 for use in patients with relapsed or refractory PTCL, and approved Istodax (romidepsin, Celgene Corp.) in 2011 for the treatment of PTCL in patients who had received at least one prior therapy.

The safety and effectiveness of belinostat were evaluated in a clinical study involving 129 patients with relapsed or refractory PTCL. All of the patients were treated with belinostat until their disease progressed or until side effects became unacceptable. A complete or partial response was achieved by 26% of the patients. The most common side effects were nausea, fatigue, pyrexia, anemia, and vomiting.

The FDA’s accelerated approval program allows the approval of a drug based on surrogate or intermediate endpoints that are reasonably likely to predict a clinical benefit for patients with serious conditions with unmet medical needs. Drugs receiving accelerated approval are subject to confirmatory trials that verify their clinical benefit. Belinostat also received an “orphan product” designation from the FDA because it is intended to treat a rare disease or condition.

Source: FDA; July 3, 2014.

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