Treanda is now FDA approved. A study of with Treanda (bendamustine)published in the Journal of Clinical Oncology in May 2005 showed significant activity of Treanda and Rituxan® (Rituximab) for the treatment of relapsed or refractory low-grade NHL or mantle cell lymphoma. A multicenter U.S. and Canadian trial of Treanda evaluated Treanda in combination with Rituxan in 67 patients with indolent or mantle cell lymphoma who had failed chemotherapy was presented at ASH 2005. Thirty-seven per cent had also failed Rituxan. The overall response rate was 87% with complete responses observed in 33%. The most frequent complications were related to reversible myelotoxicity.
German researchers reported similar complete remission rates but an improved 5 year survival with BOP (61%) compared to COP (46%). Another study presented at ASH 2005 was performed in 17 sites in the United States and Canada and involved 77 patients with relapsed or refractory NHL. Approximately half the patients had follicular NHL and the remainder had more aggressive histologies. All were treated with single agent Treanda, which resulted in an overall response rate of 74% with a complete response rate of 39%. The median duration of response was 6.6 months with a longer duration for follicular lymphoma and a shorter duration of response for patients with transformed histology. Side effects were predominantly related to myelosuppression
On October 31, 2008, the U.S. Food and Drug Administration (FDA) approved bendamustine hydrochloride (TREANDA®, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Kath R, Blumenstengel K, Fricke HJ, Höffken K (January 2001). “Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia”. J. Cancer Res. Clin. Oncol. 127 (1): 48–54
Robinson KS, Williams ME, Cohen P, et al. Bendamustine HCL (TREANDA) plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin’s lymphoma: a phase II study. Blood. 2005;106:271a, abstract # 923.
Friedberg JW, Cohen P, Cheson BD, et al. Bendamustine HCL (Treanda) results in high rate of objective response in patients with rituximab-refractory and alkylator-refractory indolent B-cell non-Hodgkin’s lymphoma (NHL): results from a phase II multicenter single-agent study (SDX-105-01). Blood . 2005;106:70a, abstract # 229.