FDA approves risk management program on ESA's for treating anemia due to chemotherapy

The U.S. Food and Drug Administration today approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy.

ESAs, which include epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen Inc. ESAs are forms of the human protein erythropoietin, which stimulates bone marrow to make red blood cells.

In April 2008, FDA required Amgen Inc. to establish this risk management program based on studies that found that ESAs caused tumors to grow faster and resulted in earlier deaths in some cancer patients.

Amgen's risk management program, referred to as a REMS or Risk Evaluation and Mitigation Strategy, requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

In addition, the company's APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program, which is part of the REMS, requires specific training and certification of health care professionals who administer chemotherapy to patients with cancer and counseling of their patients. It does not apply to patients being treated with an ESA for anemia due to other circumstances.

"Evaluation of Erythropoiesis-Stimulating Agents has been an ongoing and intensive process since 2004, involving a series of public meetings, labeling changes, and a required Medication Guide," said Richard Pazdur, M.D., director of the Office of Oncology Products in the FDA's Center for Drug Evaluation and Research. "This new risk management program will help ensure that patients and their health care professionals have fully considered the benefits and risks of using ESAs."

Through the risk management program, Amgen must ensure that health care professionals who treat patients with cancer do the following:

• Register and maintain active enrollment in the ESA APPRISE program,
• Complete a special training module on how to use ESAs in patients with cancer, and
• Discuss the risks, benefits, and FDA-approved uses of ESAs with patients who have cancer before beginning a course of ESA treatment and document this discussion with a written acknowledgement from the patient.

Amgen is also required to oversee and monitor health care professionals and hospitals that use ESAs for patients with cancer to ensure that these caregivers are fully compliant with all aspects of the overall risk management program.

ESAs are approved for the treatment of anemia that may occur as a result of kidney failure, from certain kinds of chemotherapy, from the drug AZT, which can be used for the treatment of HIV infection, and for the treatment of anemia among certain patients undergoing surgery.  

Procrit, Epogen and Aranesp are manufactured by Thousand Oaks, Calif-based Amgen.

FDA Office of Oncology Drug Products
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm