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| |  FDA Approves Rituximab to Treat Chronic Lymphocytic Leukaemia ROCKVILLE, Md -- February 18, 2010 -- The US Food and Drug Administration today approved rituximab (Rituxan), a monoclonal antibody, to treat certain patients with chronic lymphocytic leukaemia (CLL). “[Rituximab] 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, Office of Oncology Drug Products, FDA Center for Drug Evaluation and Research, Rockville, Maryland. 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. Rituximab is administered with 2 other chemotherapy drugs, fludarabine and cyclophosphamide. The 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. The safety and effectiveness of rituximab was evaluated in 2 studies that measured progression-free survival, defined as the time a patient in the study lived without the cancer progressing. In 1 study of 817 patients who had not received any prior chemotherapy, progression-free survival was 8 months longer for those receiving rituximab plus chemotherapy than for those who received chemotherapy alone. In another study of 522 persons whose cancer had progressed following other chemotherapy drugs, progression-free survival was 5 months longer for those who received rituximab plus chemotherapy. The FDA analysed the data on patients 70 years of age and older who had received rituximab and found no evidence that adding the drug to chemotherapy benefitted elderly patients compared to receiving chemotherapy alone. However, there was also no evidence that rituximab was harmful to elderly patients. Rituximab carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Some 59% of patients treated with rituximab for CLL experienced an infusion reaction that resembled an allergic reaction (eg, hives, low blood pressure, chills, fever, and nausea). A decrease in infection-fighting, normal white blood cells was also commonly observed in patients enrolled in the rituximab clinical trials. Other Boxed Warnings for rituximab include rashes and sores in the skin and mouth; progressive multifocal leucoencephalopathy, a brain infection that is generally fatal; and tumour lysis syndrome, which results from the death of a large number of tumour cells in a short period of time. When the tumour cells are killed by the drug, they release toxins into the bloodstream that can cause acute kidney injury and increase the levels of potassium and phosphate in the blood. SOURCE: US Food and Drug Administration
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