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ODAC won't rush to judgment on EPO

Although encouraged by FDA officials to endorse new clinical trials to assess the safety of long-marketed erythropoietin products as they are now used to treat anemia in cancer patients, members of the Oncologic Drugs Advisory Committee have concluded that the questions are likely to be addressed adequately by clinical trials already in progress.

Last week's meeting was convened to discuss adverse safety signals in trials that used off-label EPO regimens to intentionally boost hemoglobin above normal levels to potentiate radiation therapy or chemotherapy in cancer patients.

In two European trials discussed at the meeting - the Breast Cancer Erythropoietin Trial (BEST, EPO-INT-76) of Eprex epoetin alfa, which is manufactured by Johnson

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