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Thursday, July 3, 2014

FDA Approves Beleodaq for PTCL


The U.S. Food and Drug Administration has today approved Beleodaq (belinostat) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma. The drug works by stopping enzymes that contribute to T-cells.


“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”


The FDA had previously approved Folotyn (pralatrexate) for the treatment of patients with relapsed or refractory PTCL (2009), as well as Istodax (romidepsin) for the treatment of patients with PTCL who had received at least one prior therapy (2011)(OT 7/11/14 issue).


Beleodaq was approved under the agency’s accelerated approval program, which allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs. In 2014, 70,800 Americans will be diagnosed with NHL and 18,990 will die, according to National Cancer Institute estimates. Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit. Beleodaq also received orphan product designation by the FDA because it is intended to treat a rare disease or condition.


The 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 became unacceptable. Results showed 25.8 percent of participants had their cancer disappear or shrink after treatment.


The most common side effects seen the patients treated with Beleodaq were nausea, fatigue, pyrexia, anemia, and vomiting.


Beleodaq is marketed by Spectrum Pharmaceuticals, Inc.