An advisory panel to the US Food and Drug Administration (FDA) has recommended that the agency further limit the use of erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in patients with cancer. The recommendations come in the wake of recent reports suggesting that the drugs shorten survival time and promote faster tumor growth in such patients.
On March 13, the FDA's Oncologic Drug Advisory Committee (ODAC) said that companies manufacturing ESAs should be allowed to continue marketing the drugs for approved oncological indications. But the committee recommended labeling specifying that ESAs should not be given to patients with curable cancers or metastatic breast and/or head and neck cancer, and said that the FDA should mandate the provision of consent forms to patients receiving ESAs for chemotherapy-induced anemia.
Mitka M. New Limits Advised for Anemia Drugs. JAMA. 2008;299(17):2016. doi:10.1001/jama.299.17.2016