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Beleodaq® Drug to Treat Rare Form of Non-Hodgkin Lymphoma Receives Accelerated FDA Approval

On July 3, 2014, the U.S. Food and Drug Administration (FDA) approved Beleodaq® (belinostat) as a treatment for Peripheral T-Cell Lymphoma (PTCL). PTCL is a rare and fast-growing type of Non-Hodgkin Lymphoma (NHL) in which the lymph nodes become cancerous.

Beleodaq®, which received accelerated approval, is designed to stop enzymes that contribute to T-cells, a type of immune cell, from becoming cancerous. The drug is intended for patients whose disease returned after receiving initial treatment (relapse) or did not respond to previous treatment (refractory).

The drug’s safety and effectiveness were evaluated in a clinical study involving 129 subjects with relapsed or refractory PTCL. All participants were treated with Beleodaq® to the point where their disease progressed or side effects became unacceptable. The results showed 25.8% of subjects had their cancer disappear or shrink after treatment.

Dr. Richard Pazdur, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said that “[the] approval expands the number of treatment options available to patients with serious and life-threatening diseases.” Beleodaq® is the third drug that has been approved to treat PTCL since 2009.

The other two drugs to receive accelerated approval include Folotyn® (pralatrexate), for patients with relapsed or refractory PTCL, and Istodax® (romidepsin), for patients who received at least one prior therapy to treat PTCL. Folotyn® was approved in 2009 and is marketed by Spectrum Pharmaceuticals, Inc. based in Henderson, Nevada. In 2011, the FDA approved Istodax®, which is marketed by Celgene Corporation based in Summit, New Jersey.


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