A New Drug Application (NDA) has been submitted to the United States Food and Drug Administration (FDA) by Cephalon, Inc. for their investigative agent Treanda (bendamustine HCl) for the treatment of indolent B-cell non-Hodgkin’s lymphoma (NHL).
Specifically, the NDA submitted requests treatment utilizing Treanda in indolent B –cell NHL that has progressed during or following prior therapy with Rituxan® (rituximab) or Rituxan-containing regimens.
Treanda is considered a chemotherapy agent that is a hybrid of a purine analog and an alkylator. Treanda causes apoptosis as well as mitotic catastrophe in the damage of cancer cells.
Treanda has received priority review and orphan drug status for the treatment of chronic lymphocytic leukemia based on an NDA submitted to the FDA in September 2007.
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