The U.S. Food and Drug Administration (FDA) will no longer require risk evaluation and mitigation strategy (REMS) certification prior to the administration of two erythropoiesis-stimulating agents (ESAs): epoetin alfa and darbepoetin alfa. These agents are approved for the treatment of anemia caused by myelosuppressive chemotherapy.
“The FDA has released the REMS requirements for the ESA products … and the risks can be communicated by the current product prescribing information,” the agency noted in a press release announcing the decision. “The appropriate use of ESAs is supported by the CMS National Coverage Determination, the American Society of Clinical Oncology, and American Society of Hematology clinical guidelines.”
The FDA issued the REMS requirement in 2010 to mitigate the risks of adverse events associated with ESAs. 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 found that prescribers demonstrated acceptable knowledge of product risks. The drug use data also indicated that the agents were being appropriately prescribed for their intended use.
Based on these findings, the FDA determined that the ESA REMS was no longer necessary to “ensure the benefits [of ESAs] outweigh the risks, the serious risks of shortened overall survival and/or increased risk of tumor progression or recurrence associated with [ESAs] remains a concern.” Though these agents still carry risks, the FDA determined that the prescribing information properly communicates the information.
Source: FDA news release, April 13, 2017.