FDA Approves Rituxan for Chronic Lymphocytic Leukemia

February 19, 2010

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

The US Food and Drug Administration has approved San Francisco-based Genentech’s (a member of the Roche Group) Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

Rituxan, an blockbuster cancer drug, 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. Rituxan is administered with two other chemotherapy drugs, fludarabine and cyclophosphamide.

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

Rituxan is also used in combination with other cancer medicines to treat non-Hodgkin's lymphoma. It is also used in combination with another drug called methotrexate to treat symptoms of adult rheumatoid arthritis.
 

FDA’s release