Cephalon submits application for Non-Hodgkin’s Lymphoma drug

Cephalon has submitted a New Drug Application (NDA) to the US Food and Drug Administration for the approval of Treanda in the treatment of patients with relapsed indolent Non-Hodgkin’s Lymphoma (NHL).

Treanda (bendamustine HCl) is an injection indicated for use in patients with indolent B-cell NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen.

Dr Lesley Russell, executive vice-president of worldwide medical and regulatory operations at Cephalon, confirmed that the NDA submission was a “significant milestone” with Treanda being the lead product in its oncology pipeline.

She added: “The clinical data supporting this submission highlights the potential of Treanda to make a meaningful difference for patients with indolent NHL who have relapsed during or following treatment with rituximab.”

In particular, the NDA was supported by three studies in patients with NHL which included one trial investigating Treanda in combination with rituximab.

All three studies showed that patients treated with Treanda had a high rate of response and was well tolerated with adverse events similar to those with other chemotherapy agents.

Last month, Cephalon announced that Treanda could make a significant difference to patients with chronic lymphoctyic leukaemia.