Cephalon Gains Additional FDA Approval for Treanda

Cephalon, Inc., received approval from the FDA for Treanda for Injection for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. In March, Treanda received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the U.S.

     Indolent NHL, a subset of non-Hodgkin’s lymphoma, is a slow-growing but serious cancer of the lymphatic system that is not curable with currently available treatments. Patients with indolent NHL are prone to multiple relapses after initial therapy. According to the National Cancer Institute, an estimated 30,000 people in the will be diagnosed this year with indolent NHL.

     The FDA approval is supported by a 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. The study demonstrated that patients had a high response rate to treatment with Treanda, and these responses to the treatment were durable. The results showed that treatment with Treanda as a single agent resulted in an overall response rate of 74%, which means that after treatment, the cancer diminished or disappeared in approximately three out of four patients. Additionally, patient response to treatment in the pivotal study lasted a median of 9.2 months and patients remained alive and their disease did not progress for a median of 9.3 months.