NAPSR News: FDA Approves Spectrum's Beleodaq to Treat Rare Form of non-Hodgkin Lymphoma

July 7, 2014 - PRLog -- On July 3, 2014, the FDA announced the approval of Beleodaq to treat patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL) evident from cancerous lymph nodes. The approval of Beleodaq was categorized under the FDA’s accelerated approval program based on tumor response rate and duration of response. The FDA also gave Beleodaq an orphan product designation because it is intended to treat a rare disease or condition.

According to the National Cancer Institute there is an estimated 70,800 Americans that will be diagnosed with NHL in 2014 and approximately 18,990 will die. PTCL represents about 10 to 15 percent of NHLs in North America. Beleodaq's efficacy is derived from its ability to impede the enzymes that contribute to T-cells, a type of immune cells, becoming cancerous. Beleodaq is a histone deacetylase inhibitor indicated specifically for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) In other words, for patients whose disease returned after treatment or lack or response to previous therapies.

This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Today's approval expands the number of treatment options available to patients with serious and life-threatening diseases."

Beleodaq’s safety and effectiveness was evaluated in a clinical study involving 129 participants with relapsed or refractory PTCL. Clinical data showed 25.8% of participants experienced a complete response as their cancer disappeared while others exhibited partial response by the cancer shrinking.

Beleodaq is marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, Nevada and with the FDA Approval, Spectrum had an intraday rise to a high of $9.26, a nearly 6.2% increase later giving up some of that gain and closed at $8.90, up 2.06%, according to USA Today .

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