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12:00 AM
May 10, 2004
 |  BioCentury  |  Regulation

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 & Johnson, and a trial of NeoRecormon epoetin beta, made by Roche (SWX:ROCZ, Basel, Switzerland) - exposure to EPO was associated with reduced overall survival and progression-free survival, and increased thrombotic events, compared to placebo (see "Sending Signals").

The negative outcomes were a surprise.

Neither of the products studied in the BEST and NeoRecormon trials is approved in the U.S. But FDA medical officer Harvey Luksenburg told the panel that the agency assumes the safety issues raised in Europe apply to epoeitin alfa manufactured by Amgen Inc. and marketed by AMGN as Epogen and by JNJ as Procrit, as well as to AMGN's second-generation...

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