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Home Industry News Cephalon’s Treanda receives FDA approval

Cephalon’s Treanda receives FDA approval

3rd November 2008

Cepahlon’s drug to treat patients with Relapsed Indolent non-Hodgkin’s Lymphoma (NHL), Treanda, has received approval by the US Food and Drug Administration (FDA).

The approval of Treanda (bendamustine hydrochloride) follows a previous green light by the FDA for use as a treatment of patients with chronic lymphocytic leukemia, the most common form of the cancer in the US.

It also follows a pivotal trial of 100 patients with indolent B-cell NHL who had progressed during or within six months of treatment with a regimen that included rituximab.

Indolent NHL is a subset of non-Hodgkin’s lymphoma (NHL) and is a slow growing but serious cancer of the lymphatic system that is not curable with current treatments available. Figures by the National Cancer Institute found that approximately 30,000 people in the US will be diagnosed with the disease this year.

Dr Bruce Cheson, Treanda clinical investigator and professor of medicine at Georgetown University Hospital, Washington DC said: “Because most patients with indolent non-Hodgkin’s lymphoma eventually become resistant to existing treatments, new treatment options like Treanda are needed to improve patient outcome.

“The Treanda pivotal trial shows that it is an effective and well tolerated chemotherapy,” he added.

Founded in 1987, Cephalon currently employs approximately 3,000 staff in the US and Europe, with headquarters in Frazer, Pennsylvania and Maisions-Alfort, France.

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