FDA Okays Beleodaq to Treat Non-Hodgkin Lymphoma

The U.S. Food and Drug Administration, to treat a rare and aggressive form of non-Hodgkin Lymphoma, gave a nod to Beleodaq.

Peripheral T-cell lymphoma (PTCL) is a rare and fast growing type of non-Hodgkin lymphoma (NHL).  PTCL consists of a varied group of rare disease where the lymph nodes become cancerous. The National Cancer Institute estimated that in 2014, nearly 70,800 Americans will be diagnosed with NHL and nearly 18,900 will die. PTCL represents 10-15 percent of NHLs in North America.

This new drug - Beleodaq - approved by Spectrum Pharmaceuticals treats PTCL. The action was taken under the agency's accelerated approval program.

"This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma," said Richard Pazdur, M.D., 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."

The newly approved drug Beleodaq functions by curbing the enzymes that contribute to T-cells, which is a type of immune cell, becoming cancerous. The drug is for those in whom the disease relapsed or did not respond to the previous treatment (refractory).

In 2009, the federal regulators approved Folotyn for patients with relapsed or refractory PTCL. And in 2011, they approved Istodax to treat PTCL in patients who received at least one prior therapy.

The authorities tested the safety and effectiveness of the drug in a clinical study that consisted of 129 participants with relapsed or refractory PTCL. All the participants were treated with Beleodaq until their disease either progressed or side effects became unacceptable. The researchers noticed that 25.8 percent of the participants' cancer disappeared (showing complete response) or their cancer shrunk (showing partial response) after the treatment.

The side effects noticed was nausea, fatigue, fever, lower red blood cells and vomiting.