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news.Genentech and Biogen Idec have filed two supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) for the approval of Rituxan (rituximab) plus standard chemotherapy. Rituxan will be used for patients suffering from chronic lymphocytic leukemia (CLL).
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CLL is caused when too many abnormal white blood cells are developed in blood and bone marrow. The abnormal cells surpass the number of normal white blood cells, making the body difficult to fight infection.
Two phase III clinical trials conducted on nearly 1,500 CLL patients demonstrated the positive results. Cecil Pickett, President of Research and Development, Biogen, said: “There is no cure for CLL, and the primary goal of treatment is to keep the cancer from getting worse. These data showed that Rituxan was able to extend the period of time before cancer progression by about 10 months for people with newly diagnosed or recurrent disease.”