Centocor Ortho Biotech Products, L.P. and Amgen, Inc. announced on February 16, 2010 that the FDA approved a REMS for erythropoiesis-stimulating agents (ESAs). A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. If the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure that the benefits of a drug or biological product outweighs the risk of the product, a REMS is required and the FDA is responsible for notifying the sponsor.

REMS
A REMS can take several forms:  

REMS and ESAs
The REMS for ESAs includes the agents Procrit®(epoetin alfa), Aranesp® (darbepoetin alfa) and Epogen® (epoetin alfa). A REMS was determined necessary by the FDA to ensure the benefits of the agents outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as found in clinical trials of patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.1

The goal of the ESA REMS is to provide support regarding informed decisions between patients and their healthcare providers who may be considering treatment with the above products. The REMS will educate them on the risks of ESAs, and for treatment of patients with cancer, the goal is to mitigate the risk of decreased survival and/or poorer tumor outcomes.

REMS, ESAs and the APPRISE Program
The REMS for ESAs includes the APPRISE Program (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs), which will be launched on March 24, 2010. Components of the APPRISE include:  

  • Distribution of a “Dear Healthcare Provider” letter introducing the program and providing the rationale
  • Program objectives
  • Training and enrollment requirements
  • Consequences for non-enrollment
  • All healthcare providers and hospitals who prescribe, or prescribe and dispense ESAs for patients with cancer will be able to train and enroll in the ESA APPRISE Oncology Program by contacting their local Amgen or Centocor Ortho Biotech Products field representative
  • Healthcare providers may also access the ESA APPRISE Program website at www.esa-apprise.com (not available until March 24)
  • All providers intending to prescribe or prescribe and dispense these agents to patients with cancer
    • Must train and enroll in the ESA APPRISE Program
    • Must document with each patient that a discussion took place regarding the risks of ESAs prior to the initiation of each new course of ESA therapy
    • Provide to all patients a medication guide explaining the risks and benefits of ESAs therapy

More information regarding the complete ESA APPRISE Program may be obtained at Amgen or Centocor Ortho Biotech.

Reference

  1. BioTech-Intelligence. Amgen and Centocor Ortho Biotech Products Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA.  Accessed from: http://www.biotech-intelligence.com/html/html/pool_7/e65cb1998d39475e103d2577135e6ead.html.