Amgen in discussions to update US ESA labels

World biotechnology giant Amgen is in discussions with the US Food and Drug Administration aiming to update safety information on the labels on all erythropoiesis-stimulating agents, based on worrying safety data from the interim results of the PREPARE study in neoadjuvant breast cancer and the recently-published follow-up data from the Gynecologic Oncology Group study in cervical cancer (Marketletter December 4).

Amgen and the FDA are discussing the label changes under a regulatory mechanism known as the "changes being effected" process. Additionally, Amgen has been advised there will be an Oncologic Drugs Advisory Committee meeting in the first quarter of 2008 as part of the ongoing pharmacovigilance review of ESAs. Decisions around the precise timing of this ODAC meeting will not be finalized until publication by the FDA in the Federal Register.

Last month, the agency approved revised boxed warnings on ESAs to address the risks that Amgen's Aranesp and Epogen (epoetin alfa) and health care giant Johnson & Johnson's Procrit (epoetin alfa) pose to patients with cancer and chronic kidney failure after they were linked to higher tumor growth rates and increased risk of death in cancer patients (Marketletter November 19).