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 transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
CONTACT: Stephanie Fagan for Ortho Biotech Products, L.P., +1-908-541-4029
office, +1-201-572-9581 cell, or sfagan@obius.jnj.com
Web site: http://www.orthobiotech.com/
http://www.procrit.com/
http://dx.doi.org/10.1016/j.ygyno.2007.10.011/
