Tuesday, April 1, 2014

Beleodaq gets FDA approval for the treatment of patients with T-cell lymphoma peripheral

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Beleodaq gets FDA approval for the treatment of patients with T-cell lymphoma peripheral -

The Food and Drug Administration of the United States today approved Beleodaq ( belinostat) for the treatment of patients with peripheral T -cell lymphoma (PTCL), a type fast growth and rare non-Hodgkin lymphoma (NHL). The action was taken under the accelerated approval program of the agency.

PTCL comprises a diverse group of rare diseases in which the lymph nodes become cancerous. In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,90 will die. PTCL is about 10 to 15 percent of the NHL in North America.

Beleodaq works by stopping enzymes that contribute to T cells, a type of immune cell becoming cancerous. It is intended for patients whose disease recurrence after treatment (relapsed) or did not respond to previous treatment (refractory).

"This is the third drug that has been approved since 09 for the treatment of peripheral T-cell lymphoma cells," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the Center the FDA for evaluation and research on drugs. "today's approval expands the number of treatment options available for patients with serious illnesses and life-threatening."

the FDA granted accelerated approval of FOLOTYN (pralatrexate) in 09 for use in patients with relapsed or refractory PTCL and ISTODAX (romidepsin) in 2011 for the treatment of PTCL patients who received at least one prior therapy.

safety and effectiveness of Beleodaq was evaluated in a clinical study of 129 participants with relapsed or refractory PTCL. All participants were treated with Beleodaq until their disease progressed or side effects becomes unacceptable. The results showed 25.8 percent of participants had their cancer disappear (complete response) or shrinkage (partial response) after treatment.

The most common side effects in participants treated Beleodaq were nausea, fatigue, fever (pyrexia), low red blood cell count (anemia), and vomiting.

accelerated approval program allows the FDA approval of a drug based on surrogate endpoints or intermediate reasonably likely to predict clinical benefit for patients with serious illnesses with medical needs not satisfied. Drugs that receive accelerated approval are subject to confirmation tests verifying clinical benefit. Beleodaq also received orphan product designation by the FDA because it is intended to treat a rare disease or condition.

Beleodaq and FOLOTYN are marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, Nevada. ISTODAX is marketed by Celgene Corporation, headquartered in Summit, New Jersey.


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