The FDA approved belinostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The approval was done under the agency’s accelerated approval program. PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. PTCL represents approximately 10% to 15% of NHL cases in North America.
Belinostat works by preventing the development of T-cells from becoming cancerous. According to the FDA, “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.”
The safety and effectiveness of belinostat were evaluated in a clinical trial involving 129 patients with relapsed or refractory PTCL. All patients received belinostat until disease progression or until their side effects became unacceptable. In all, 25.8% of the patients showed complete or partial response after treatment with belinostat.
The most common side effects seen with belinostat were nausea, fatigue, fever, anemia, and vomiting.
Belinostat also received orphan drug designation by the FDA, because it is intended for the treatment of patients with PTCL, which is a rare disease. (July 3, 2014)
