FDA Approves Belinostat to Treat Patients with Peripheral T-cell Lymphoma

The action was taken under the accelerated approval programme

On 3 July 2014 the USA Food and Drug Administration approved belinostat (Beleodaq) for the treatment of patients with peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval programme.

Peripheral T-cell lymphoma comprises a diverse group of rare diseases. It represents about 10% to 15% of NHLs in North America.

Belinostat is a histone deacetylase inhibitor. It is intended for patients whose disease relapsed after treatment or did not respond to previous treatment (refractory setting).

“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA granted accelerated approval to pralatrexate (Folotyn) in 2009 for use in patients with relapsed or refractory peripheral T-cell lymphoma and romidepsin (Istodax) in 2011 for the treatment of peripheral T-cell lymphoma in patients who received at least one prior therapy.

The safety and effectiveness of belinostat was evaluated in a clinical study involving 129 participants with relapsed or refractory peripheral T-cell lymphoma. All participants were treated with belinostat until their disease progressed or side effects became unacceptable. Results showed 25.8% of participants had complete response or partial response after treatment.

The most common side effects seen in belinostat-treated participants were nausea, fatigue, pyrexia, anaemia, and vomiting.

The FDA’s accelerated approval programme allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs. Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit.

Belinostat also received orphan product designation by the FDA because it is intended to treat a rare disease or condition.

Belinostat and pralatrexate are marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, Nevada. Romidepsin is marketed by Celgene Corporation based in Summit, New Jersey.

Source: FDA