FDA grants accelerated approval to Beleodaq

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced approval for Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), which is a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

The drug works by stopping enzymes that contribute to T-cells becoming cancerous. It's indicated for patients whose disease has returned post-treatment or those patients who did not respond to previous 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. “Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”

In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,900 will die. PTCL makes up about 10% to 15% of NHLs in North America, the agency said.


Beleodaq is marketed by Spectrum Pharmaceuticals.

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