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Ortho Biotech Statement On JAMA Publication Regarding Erythropoiesis-Stimulating Agents
Date:2/26/2008

be underdiagnosed as a cause of death in cancer patients. For this reason, it is plausible that unrecognized VTEs are a potential explanation for increased mortality with ESAs in cancer patients, especially in those studies with high hemoglobin targets.

Mortality

Out of a total of 59 controlled studies for which mortality information has been reported, the U.S. Food and Drug Administration has characterized eight investigational studies as reporting that patients receiving ESAs had decreased overall survival and/or tumor progression compared with the control group. All eight studies were conducted in settings inconsistent with the current product label. The safety findings from these eight studies conducted outside the label have raised important questions that will be addressed through further research and risk minimization activities.

EPO Receptors

The data remain inconclusive on the hypothesis that the expression of erythropoietin receptors on tumor cells can lead to shortened survival in cancer patients. The company has proposed unrestricted funding to support independent research through the National Cancer Institute to address this hypothesis.

Ortho Biotech fully supports direction to healthcare professionals to use the lowest dose of ESAs that will gradually increase the hemoglobin concentration to a level that will avoid the need for a blood transfusion. The company believes that ESA product labeling prominently reflects all known risks of ESAs, including VTEs, when used according to the label, and increased VTEs and mortality, when used to treat beyond the correction of anemia or in cancer patients not on chemotherapy.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the ne
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