FDA approves third treatment for PTCL

July 8, 2014

FDA has approved another treatment for patients with peripheral T-cell lymphoma (PTCL), a rare yet aggressive type of non-Hodgkin lymphoma. Belinostat (Beleodaq) by Spectrum Pharmaceuticals was approved under FDA’s accelerated approval program. It is indicated for patients with relapsed or refractory PTCL.

FDA has approved another treatment for patients with peripheral T-cell lymphoma (PTCL), a rare yet aggressive type of non-Hodgkin lymphoma. Belinostat (Beleodaq) by Spectrum Pharmaceuticals was approved under FDA’s accelerated approval program. It is indicated for patients with relapsed or refractory PTCL.

Non-Hodgkin lymphoma is estimated to affect approximately 70,800 Americans in 2014 and nearly 19,000 will be fatal cases, according to the National Cancer Institute. PTCL involves about 10% to 15% of non-Hodgkin lymphoma cases in the United States and Canada.

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

In 2009, FDA approved pralatrexate (Folotyn, Spectrum Pharmaceuticals) for patients with relapsed or refractory PTCL and in 2011, the agency approved romidepsin (Istodax, Celgene Corp.) for the treatment of PTCL in patients who had received at least one prior therapy.

Belinostat’s approval was based on the results of a clinical trial of 129 patients with relapsed or refractory PTCL. They were treated until disease progression or side effects were intolerable. Common side effects included nausea, fatigue, pyrexia, anemia, and vomiting.

Nearly 26% had a complete or partial response to belinostat, according to the FDA.