The FDA has granted marketing approval for the chemotherapy agent bendamustine (Treanda) to be used in patients with indolent B-cell non-Hodgkin lymphoma (NHL), the drug's manufacturer Cephalon announced on October 31. The approval covers the use of bendamustine in patients whose disease has progressed during or within 6 months of treatment with the monoclonal antibody rituximab (Rituxan) or a treatment regimen that includes rituximab. In March, the FDA approved bendamustine for use in patients with chronic lymphocytic leukemia.

The approval was based on the results of a phase III, 100-patient, single-arm clinical trial. The overall response rate - that is, the combination of complete or partial responses - was 75 percent and the median duration of the response was 9.2 months. Results from the trial were presented in December 2007 at the American Society of Hematology annual meeting. Side effects from the treatment included fatigue, nausea, and vomiting, among others, the company reported.

In 2007, there were approximately 30,000 cases of indolent, or slow-growing, NHL in the United States. "Because most patients with indolent NHL eventually become resistant to existing treatments, new treatment options like bendamustine are needed to improve patient outcome," said Dr. Bruce Cheson, director of hematology at the Lombardi Comprehensive Cancer Center in Washington, D.C., in a news release.

The drug is also being tested in a clinical trial in combination with rituximab as a first-line therapy for NHL.