The FDA last Friday granted approval to Cephalon, Inc. to market the drug Treanda ^[1] (bendamustine) for the treatment of indolent non-Hodgkin’s lymphoma (NHL).

Just seven months ago, the FDA also approved Treanda for the treatment of chronic lymphocytic leukemia (CLL), making Treanda the only new drug this year to gain FDA approval for two cancer indications.

Treanda is not officially approved in the United States for the treatment of multiple myeloma ^[2]. It is, however, approved in Germany for multiple myeloma as well as indolent NHL and CLL.

Treanda is a hybrid of a purine analogue and an alkylator. While the exact way it works remains unknown, preclinical studies suggest it may kill cancer by damaging DNA and disrupting division of cancer cells. The drug is administered as an intravenous infusion over a period of sixty minutes.

In the most recent clinical study with indolent NHL patients, the most serious adverse events in study participants were myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions, and other related malignancies. These reactions are “things that are generally manageable, and nothing we wouldn’t expect in a typical oncology setting,” stated Charles Morris, Cephalon’s vice president of worldwide clinical research. In indolent NHL patients, Treanda achieved an overall response rate of seventy-four percent.

Source: Cephalon.com ^[3]