FDA Lifts REMS Requirement for ESAs for Anemia

The U.S. Food and Drug Administration (FDA) has lifted its risk evaluation and mitigation strategy (REMS) certification requirement for erythropoiesis-stimulating agents (ESAs), specifically epoetin alfa and darbepoetin alfa, for anemia related to myelosuppressive chemotherapy. The drugs are approved for anemia resulting from chronic kidney disease, chemotherapy, certain HIV treatments, and reduction in the number of blood transfusions during and after certain major surgeries.

“The appropriate use of ESAs is supported by the Centers for Medicare and Medicaid Services’ (CMS) National Coverage Determination, the American Society of Clinical Oncology, and the American Society of Hematology clinical guidelines, which are evidence-based guidelines intended to provide a basis for the standard of care in clinical oncology,” the FDA said in a statement about this revision.

The FDA issued the REMS requirement in 2010 to mitigate the risks of adverse events (AEs) associated with ESAs that were identified in pivotal clinical trials, including a shorter overall survival (OS) and/or increased risk of progression or recurrence in patients with breast cancer, non-small cell lung cancer, head and neck cancer, lymphoid cancer, and cervical cancer. Under this program, providers and hospitals were required to become certified in the ESA REMS, provide counseling to each patient, and have each patient complete a Patient and Healthcare Provider Acknowledgment Form prior to treatment with the agents.

After conducting a REMS assessment and surveying prescribers, the FDA determined that the ESA REMS was no longer necessary to “ensure the benefits [of ESAs] outweigh the risks.” In data from 2006 to 2014, Amgen (the manufacturer of darbepoetin alfa) demonstrated a decrease in the number of patients receiving chemotherapy who warranted ESAs, suggesting a lower overall risk. In addition, trend analysis showed that the introduction of the REMS had little impact on ESA usage.

“The prescribing information continues to note an increased risk of tumor progression or recurrence, as well as death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access,” the FDA cautioned. The labels for both treatments note that they should only be used with myelosuppressive chemotherapy when at least 2 months of treatment with chemotherapy are planned. The agents also should not be used in combination with hormonal agents, biologic products, or radiotherapy, unless the patient is also receiving myelosuppressive chemotherapy.

Source: U.S. Food and Drug Administration news release, April 13, 2017.