Pharmaceutical Business review

Cephalon submits NDA for lymphoma drug

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.”