FDA Approves Updated Label for ESAs over Risks in Patients with Cancer

March 10, 2008 – The FDA approved a revised label for erythropoiesis-stimulating agents (ESAs) including Amgen's Aranesp and Epogen as well as Johnson & Johnson's Procrit. As part of the changes, the boxed warning has been updated to state that ESAs "shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small-cell lung, head and neck, lymphoid, and cervical cancers, when dosed to target hemoglobin of greater than or equal to 12 grams per d/l."

The revised label has also been updated to include additional data from studies of the product in the oncology setting. ESA labels were updated in November to include additional information about the risks of the drugs in patients with cancer and chronic renal failure.

An FDA oncology advisory panel is scheduled to meet on March 13 to discuss updated safety information for ESAs in patients with cancer. ASH will be presenting at this meeting and will provide information about the meeting following.