FDA Approvals Beleodaq Approved for Aggressive non-Hodgkin Lymphoma -- Scott Roberts

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THURSDAY, July 3, 2014 (HealthDay News) -- Beleodaq (belinostat) has been approved by the U.S. Food and Drug Administration to treat peripheral T-Cell lymphoma (PTCL), a rare and aggressive form of non-Hodgkin lymphoma (cancer of the lymph nodes).

Some 70,800 Americans will be diagnosed with non-Hodgkin lymphoma this year, of which up to 15 percent will be PTCL, according to U.S. National Cancer Institute estimates.

Beleodaq is designed to inhibit immune cells called T-cells from becoming cancerous, the FDA explained Thursday in a news release. The drug is intended for people whose cancer has returned or who didn't respond to a prior therapy, the agency said.

Beleodaq's safety and effectiveness were evaluated in clinical studies involving 129 people with PTCL. All were treated with the newly approved drug, and about 26 percent had their cancer disappear or shrink, the FDA said.

The most common side effects noted were nausea, vomiting, fatigue, fever and low red blood cell count (anemia).

Beleodaq is marketed by Spectrum Pharmaceuticals, based in Henderson, Nev.

More information

To learn more about this approval, visit the FDA.

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