Amgen statement on the Gynecologic Oncology Group study on Epoetin Alfa

This Ortho Biotech-funded ESA study by the independent Gynecologic Oncology Group enrolled 109 patients with cervical cancer and targeted high hemoglobin (> 12 g/dL) levels in the ESA-treated group. As stated in FDA’s 2004 ODAC briefing materials, there was a DSMC review in Sept. 2003, during which an increase in the number of thromboembolic events was noted. Although the DSMC did not recommend that the study be stopped as a result, the study was closed at the request of the sponsor. The study enrolled less than 25% (109 out of 460 patients) of the planned accrual. New results, including long-term follow-up for those who were enrolled in the study, have just become available.

Amgen believes this study contains information relevant to specific patient populations receiving ESAs. The study showed overall survival was 74% in the control group compared with 60% receiving ESAs at 3 years. Progression free survival at 3 years was 66% in the control group compared with 58% in the ESA group. 

Amgen notified the FDA about the three-year follow-up results on Dec. 4, 2007, upon learning of the results and is working with Ortho Biotech to provide the data to regulatory agencies.

Amgen is committed to an ongoing assessment of the risks and benefits of ESA use in cancer. As new information becomes available, we will communicate the data and, where appropriate, update our product labels. Further studies designed to assess the risk associated with ESAs use in chemotherapy-induced anemia in specific tumor types are being developed in collaboration with FDA.

To view the study, click here.