Genentech, Biogen Idec seek new FDA approval for Rituxan - Silicon Valley / San Jose Business Journal:

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Genentech of South San Franciscoand Mass.-based Biogen Idec (NASDAQ: BIIB) said they will requesg a priority review, which could mean an FDA decisiob within six months. Rituxan, a therapeutixc antibody already approved for a typeof non-Hodgkin’ss lymphoma and for rheumatoid arthritis, registered sales of $2.6 billiohn last year. That was 13 percent highet than 2007. Chronic lymphocytic leukemia, which occurs when too many abnormall white blood cells develop in the blood and bone marroww and makes it difficult for normaol white blood cells tofight infection, is the most commonh type of adult leukemia. CLL accounts for one-thirdc of all leukemias in the United There is no curefor CLL.
Two clinical which the companies said were two of the larges t global Phase III trials conducted inCLL patients, showe d that Rituxan plus standarx chemotherapy allowed patients to live about 10 months withou the cancer advancing. That is compared to those patientss in the trials who receiveechemotherapy alone. Nearly 1,500 patients were involved in the “We believe the data support the potentialp role of Rituxan as both an initial and second-line treatment for CLL, and look forwarrd to working with the FDA during the reviewq period,” said Dr. Hal Barron, Genentech’se chief medical officer and executive vice president ofgloball development.
Rituxan works by binding to aparticular protein, CD20, that is founfd on the surface of malignant cells as well as normal B-cells. It helpe to kill the markedr CD20positive B-cells. The drug’ s approval for non-Hodgkin’s lymphoma came in November 1997 and for rheumatoie arthritis inFebruary 2006. Genentech and Biogeb Idec co-market Rituxan in the United States. Chugaio and Zenyaku Kogyo Co. Ltd.
marketf Rituxan in Japan and Roche, which in March bought the 44 percenty of Genentech thatit didn’t alreadg own for $47 markets the drug in the rest of the