Cephalon, Inc. announced that the U.S. Food and Drug Administration has accepted the company's new drug application for Treanda(bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen. According to the National Cancer Institute, an estimated 30,000 people in the United States were expected to be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment. Cephalon submitted the Treandaapplication for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 31, 2008.

"We are pleased that the application for Treandato treat relapsed indolent NHL is on track. With two NDAs for Treandapending review decisions, 2008 is a significant year for this product and bodes well for the future of Cephalon in oncology," said Dr. Lesley Russell, executive vice president, worldwide medical and regulatory operations.

The TreandaNDA for relapsed indolent NHL is supported by three studies in patients with NHL, including two single-agent studies and one in combination with rituximab. In these studies, patients treated with Treandahad a high rate of response and a manageable and tolerable side effect profile, with adverse events similar to those observed with other chemotherapy agents such as myelosuppression (decrease in blood counts), nausea, and vomiting.

Back to the e-newsletter