Cephalon says 2008 a “significant year” for Treanda

Cephalon has suggested that 2008 will be a “significant year” for Treanda for Injection (bendamustine HCl) – its treatment for patients with indolent B-cell non-Hodgkin’s lymphoma (NHL).

Dr Lesley Russell, executive vice-president of worldwide medical and regulatory operations at Cephalon, made the comments following the submission of several regulatory applications for the drug this year.

Cephalon announced that the US Food and Drug Administration (FDA) had accepted the company’s new drug application (NDA) for Treanda for Injection for the treatment of patients with indolent B-cell NHL who had progressed during or following treatment with rituximab or a rituximab-containing regimen.

The pharmaceutical firm submitted the Treanda application for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 2008.

Data from three studies supported the NDA, which comprised of two single-agent trials and one in combination with rituximab.

Study data found that 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 such as myelosuppression (decrease in blood counts), nausea, and vomiting.

Also this month, Cephalon announced that new trial data showed its once-daily, extended-release muscle relaxant Amrix to be superior to placebo.