Rituxan Approved for CLL

The U.S. Food and Drug Administration approved Rituxan (rituximab) yesterday to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer. It’s not a new drug, but the approval for CLL is new.
Rituxan, a popular anti-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 given with two other chemotherapy drugs, fludarabine and cyclophosphamide.
CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells—part of the body’s immune system. Each year, about 16,000 people are diagnosed with and 4,400 die from CLL. According to the American Cancer Society, there are nearly 90,000 people in the USA living with CLL, accounting for one-third of all leukemia cases, and last year, more than 15,000 new cases were expected to be diagnosed in the country.
“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, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. Rituxan, either alone or in combination, has now achieved its fifth approval for the most common forms of non-Hodgkin's lymphoma and adult leukaemia and raked in about $6 B last year.