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Title: FDA Approves Bendamustine Hydrochloride for Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

"FDA Approves Bendamustine Hydrochloride for Patients With Relapsed Indolent Non-Hodgkin's Lymphoma"

NEW YORK -- November 3, 2008 -- The US Food and Drug Administration (FDA) has approved bendamustine hydrochloride (Treanda) for injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. "Because most patients with indolent non-Hodgkin's lymphoma eventually become resistant to existing treatments, new treatment options like [bendamustine hydrochloride] are needed to improve patient outcome," said clinical investigator Bruce Cheson, MD, Georgetown University Hospital, Washington, DC. "The [bendamustine hydrochloride] pivotal trial shows that it is an effective and well-tolerated chemotherapy that offers a delay in disease progression for more than 9 months." The FDA approval is based on a clinical trial of 100 patients with indolent B-cell NHL who had progressed during or within 6 months of treatment with a regimen that included rituximab. Treatment with bendamustine hydrochloride as a single agent resulted in an overall response rate of 74%. Additionally, patient response to treatment lasted a median of 9.2 months and patients remained alive and their disease did not progress for a median of 9.3 months. In the secondary studies for bendamustine hydrochloride in indolent NHL, the most common non-haematologic adverse reactions (frequency > 15%) were nausea, fatigue, vomiting, diarrhoea, pyrexia, constipation, anorexia, cough, headache, weight decrease, dyspnea, rash and stomatitis. The most common haematologic abnormalities (frequency >15%) are lymphopenia, leukopenia, anaemia, thrombocytopenia and neutropenia. SOURCE: Cephalon Oncology

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