On Jun. 1, 1989, the U.S. Food and Drug Administration (FDA) approved Amgen’s Epogen/Procrit for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis. On April 1, 1993 for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy. Aranesp is an Erythropoiesis-Stimulating Agents (ESAs). ESAs work like the human protein erythropoietin, which stimulates bone marrow to make red blood cells. Epogen/Procrit is also indicated for anemia due to zidovudine in patients with HIV and reduction of RBC transfusions in patients certain surgeries.

Epogen/Procrit increases the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access and tumor progession or recurrence. Epogen/Procrit can also lead to an increase in adverse cardiovascular events, hypertension, seizures, and severe anemia.

In 2008, FDA determined a REMS was necessary for the ESAs, Epogen/Procrit (epoetin alfa) and Aranesp (darbopoetin alfa), to ensure the benefits for use as treatment for anemia associated with myelosuppressive chemotherapy outweigh its risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer. The REMS was approved in 2010. Under the REMS program, referred to as the ESA APPRISE Oncology Program, healthcare providers that prescribed and/or dispensed Aranesp to patients with cancer and hospitals that dispensed Aranesp to patients with cancer were required to enroll and become certified in the ESA REMS. The ESA REMS also required a Patient and Healthcare Provider Acknowledgement Form be completed for each patient with cancer before the new ESA treatment course to ensure patients were counseled about the benefits and risks of these products.

The FDA determined that the ESA REMS, which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh its risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer.

The FDA has released the REMS requirements for the ESA products, Epogen/Procrit and Aranesp, and the risks can be communicated by the current product prescribing information. The appropriate use of ESAs is supported by the CMS NCD, the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) clinical guidelines which are evidence-based guidelines intended to provide a basis for the standard of care in clinical oncology.