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Updated Analysis of 2001 Epoetin Alfa Study Posted
Date:12/4/2007

BRIDGEWATER, N.J., Dec. 4 /PRNewswire/ -- An updated analysis from a 2001 study conducted by the Gynecologic Oncology Group evaluating Epoetin alfa in 109 patients with cervical cancer has been posted online (http://dx.doi.org/10.1016/j.ygyno.2007.10.011). The study (GOG-191) was terminated in 2003 due to potential concerns of thromboembolic events (TE) in the group treated with Epoetin alfa. The U.S. Food and Drug Administration (FDA) was notified at that time.

GOG-191 was a randomized phase III trial designed to evaluate the efficacy of maintaining hemoglobin levels above 12 grams per deciliter of blood (g/dL) with Epoetin alfa in subjects with advanced cervical cancer undergoing chemoradiotherapy. The updated analysis, expected to be published in the journal, Gynecologic Oncology, found a statistically non-significant trend toward decreased progression-free and overall survival in the patients treated with Epoetin alfa.

The updated analysis provides further evidence supporting the recent ESA class label change to utilize the lowest dose needed to avoid transfusions and not to exceed an upper hemoglobin safety limit of 12 g/dL.

Ortho Biotech has informed FDA of this updated analysis, and will continue to work with the agency and the GOG to ensure that these data are shared expeditiously with the medical community.

The safety and effectiveness of Epoetin alfa in its approved uses has been established in well-controlled studies and substantiated clinically over the past 20 years in more than four million patients worldwide for approved indications.

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 need for t
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SOURCE Ortho Biotech Products, L.P.
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