FDA Approves Rituximab for Chronic Lymphocytic Leukemia

The US Food and Drug Administration recently approved rituximab (Rituxan) to treat certain patients with chronic lymphocytic leukemia (CLL).

Rituximab is intended for patients with CLL who are beginning chemotherapy for the first time and for those who have not responded to other cancer drugs for CLL. The monoclonal antibody is administered with two other chemotherapy drugs, fludarabine and cyclophosphamide.

“Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA’s commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases,” said Richard Pazdur, MD, director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

FDA approved ofatumumab (Arzerra) in October 2009 for patients whose cancer is no longer being controlled by other forms of chemotherapy and bendamustine (Treanda) in March 2008 for patients with CLL who had not received prior treatment.