FDA Accepts Cephalon’s NDA for Lymphoma Drug

Cephalon has reported that the FDA has accepted the company’s new drug application for Treanda for injection for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma or NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen.

The Treanda NDA for relapsed indolent NHL is supported by three studies in patients with NHL, including two single-agent studies and 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 such as myelosuppression (decrease in blood counts), nausea, and vomiting.

Cephalon submitted the Treanda application for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 31, 2008.