Cephalon says that another new drug application for the use of its lymphoma drug Treanda has been accepted for review by US regulators.
The Food and Drug Administration will look at Treanda (bendamustine) for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma who have progressed during or following treatment with rituximab or a rituximab-containing regimen. An estimated 30,000 people in the USA were expected to be diagnosed in 2007 with indolent NHL, which is difficult to treat because patients are prone to relapse after treatment. Cephalon submitted the Treanda application for relapsed indolent NHL in December and it expects a decision from the FDA by October.
The Treanda NDA for the latter indication is supported by three studies which showed that patients treated with the drug had 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, nausea, and vomiting. Lesley Russell, the firm’s executive vice president, worldwide medical and regulatory operations, said that “with two NDAs for Treanda pending review decisions, 2008 is a significant year for this product and bodes well for the future of Cephalon in oncology”.
