FDA Orders Change in ESA Labeling
July 30, 2008 – The Food and Drug Administration (FDA) ordered changes in the label for erythropoiesis-stimulating agents (ESAs). These changes respond to recommendations made by the FDA's Oncologic Drugs Advisory Committee (ODAC) on March 13 of this year. They represent the first time the FDA has used its recently granted authority to order changes in drug labels rather than to negotiate with pharmaceutical companies over proposed alterations.
The label updates to the three ESAs currently on the market (Aranesp, Procrit, and Epogen) alter the previous labeling in two critical ways.
First, the FDA said the drugs should not be used with patients who are expected to be cured of cancer. Amgen, the principal manufacturer of these agents, had pressed for language that would allow for the use of ESAs in cancer patients who are expected to be cured but who cannot receive blood transfusions.
Second, the changes advise that ESA therapy should not begin when a patient's hemoglobin levels exceed or equal 10 g/dL. These restrictions were added due to concerns about possible shortened survival, increased disease progression, or thrombotic events in some patients.
The label changes are consistent with the Centers for Medicare and Medicaid Services' (CMS) national coverage decision (NCD) of July 30, 2007, which denies reimbursement for the use of ESAs at hemoglobin levels greater than 10 g/dL. CMS has indicated that there are no plans at this time to reopen the NCD. The revised label does not address the use of ESAs in patients with myelodysplasia. ASH has had much success working with local carriers to ensure that insurers allow coverage for MDS patients.
The new label changes will mostly affect adjuvant therapy for breast and colon cancer. For hematology, the changes will mostly affect the treatment for Hodgkin lymphoma, intermediate grade lymphoma, and mantel cell lymphoma where physicians have curative intent. In these cases, we can expect to see a possible increase in transfusions.
A copy of the "ASH-ASCO 2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin" is available in ASH’s scientific journal, Blood.
The new labels are available on the FDA Web site. Changes are highlighted in red.
ASH will continue to keep its members apprised of all developments.