The FDA has approved Beleodaq, a new treatment for curing peripheral T-cell lymphoma (PTCL), an aggressive form of non-Hodgkin lymphoma.
The drug was approved under the agency's accelerated approval program. Under this program, drugs are approved based on clinical evidence suggesting likely benefits for patients with serious conditions with unmet medical needs.
The effectiveness and safety of the drug was tested on a clinical trial involving 129 participants. All participants were treated with Beleodaq until their disease progressed or side effects became unacceptable. Results showed 25.8 percent of participants had their cancer disappear or shrink after treatment.
"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, in a press statement. "Today's approval expands the number of treatment options available to patients with serious and life-threatening diseases."
The FDA granted accelerated approval to Folotyn (pralatrexate) in 2009 for use in patients with relapsed or refractory PTCL and Istodax (romidepsin) in 2011 for the treatment of PTCL in patients who received at least one prior therapy.
The side effects of the drug includes nausea, fatigue, fever (pyrexia), low red blood cells (anemia), and vomiting. Beleodaq is marketed by Spectrum Pharmaceuticals.
Non-Hodgkin lymphoma (also known as non-Hodgkin's lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in cells called lymphocytes, which are part of the body's immune system. Lymphocytes are in the lymph nodes and other lymphoid tissues. There are many different types of non-Hodgkin lymphoma. These types can be divided into aggressive (fast-growing) and indolent (slow-growing) types, and they can be formed from either B-cells or T-cells. According to the National Cancer Institute, 70,800 new cases of the disease will be diagnosed in the United States in 2014, resulting in 18,990 deaths.