Amgen Discusses More ESA Labeling Updates With FDA

Amgen is in discussions with the FDA to update physician labeling for its erythropoiesis stimulating agents (ESAs) Aranesp and Epogen to reflect new safety data from two clinical trials.

The firm has been notified by the agency that another Oncologic Drugs Advisory Committee meeting is planned to discuss the products sometime in the first quarter of 2008.

The clinical data is from trials testing the drugs in patients with neoadjuvant breast cancer receiving preoperative chemotherapy and in patients with cervical cancer. The cervical cancer trial was sponsored by Johnson & Johnson (J&J), which markets Epogen (epoetin alfa) under the trade name Procrit.

Data from the breast cancer trial, which tested ESA Aranesp (darbepoetin alfa), found no statistically significant increase in deaths or tumor progression in patients dosed with the drug compared with active control.

However, there were more deaths in the Aranesp arm (50:356) than the control arm (37:377). Tumor progression also was numerically higher. Participants in the Aranesp arm maintained hemoglobin levels of 13.6 g/dL by the end of chemotherapy compared with 12.6 g/dL for the control group.

The data were generated from an interim analysis, and a final statistical assessment is expected in 2009. A boxed warning in labeling for the drugs does not include information regarding use of the products in cervical cancer. 

Results from the J&J-sponsored study showed that 60 percent of the subjects on Procrit were alive after three years compared with 74 percent for the control arm.