Amgen Rewords Label: Less Use of Procrit

Implications: The FDA required Amgen to revise the label for Procrit and Aranesp so that these agents are not used until a patient's hemoglobin drops below 10 or in the setting of potentially curative therapy.

Analysis: This is a necessary move by the FDA based on sound clinical data.  Most clinicians already have incorporated these changes into their practice over the past 6-12 months, so the impact on current care and on Amgen will likely be relatively small.  Studies in both breast cancer and head and neck cancer have indicated a potentially inferior outcome when these agents are used and already limit clinicans use of these agents for these diseases.  Whole this may lead to more fatigue in some patients, with a mild decrement in quality of life, other cancer outcomes, especially survival, may be improved.