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news.Biopharmaceutical firm Cephalon has submitted a new drug application to the FDA requesting approval of Treanda for injection 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.
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The Treanda new drug application (NDA) for relapsed indolent non-Hodgkin’s lymphoma (NHL) is supported by three studies in patients with NHL, including one in combination with rituximab. In these studies, patients treated with Treanda 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.
Lesley Russell, executive vice president, worldwide medical and regulatory operations of Cephalon, said: “Treanda is the lead product in our oncology pipeline and with this second NDA submission for the product in 2007 we have achieved a significant milestone for our business.”