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FDA accelerates approval of Beladoaq to treat peripheral T-cell lymphoma

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Beleodaq (belinostat) just received FDA approval for the for the treatment peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The drug works by stopping enzymes that can turn T-cells (a form of immune cell) cancerous. It is intended for patients whose disease returned after treatment (relapsed) or did not respond to previous treatment (refractory).

“This is the 3rd drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma, PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous.” stated the FDA’s Center for Drug Evaluation and Research director of the Office of Hematology and Oncology Products Dr. Richard Mazur. “Yesterday’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”

In 2009 the Food and Drug Administration granted accelerated approval to Folotyn (pralatrexate) 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. Beleodaq and Folotyn are both marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, NV, while Istodax is marketed by Celgene Corporation based in Summit, NJ.

So far this year, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,990 will die. PTCL represents about 10%-15% of Non Hogkins Lymphomas in the US and Canada.
To test the safety and effectiveness of Beleodaq a clinical trial was held involving 129 participants with relapsed or refractory PTCL. All were treated with Beleodaq until their disease progressed or side effects became unacceptable. Results showed that nearly 26% of the participants had their cancer disappear (complete response) or shrink (partial response) after treatment. The most common side effects reported during the Beleodaq study were nausea, fatigue, fever, low red blood cells (anemia), and vomiting.

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