Centocor Ortho Biotech Products, L.P. and Amgen Inc announced that the US Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Procrit (Epoetin alfa), Aranesp (darbepoetin alfa) and Epogen (Epoetin alfa). The US FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.
As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. To ensure continued access to ESAs for healthcare providers who prescribe, or prescribe and dispense, ESAs to patients with cancer, providers are required to train and enrol in the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Programme and to document that a discussion about the risks of ESAs took place with each patient prior to the initiation of each new course of ESA therapy. The ESA APPRISE Oncology Programme will be launched on March 24, 2010. Direct patient registration or approval prior to ESA administration is not required through the ESA APPRISE Oncology Programme.
The goal of the ESA REMS is to support informed decisions between patients and their healthcare providers (HCPs) who are considering treatment with Procrit, Aranesp or Epogen by educating them on the risks of ESAs. For treatment of patients with cancer, the goal of the REMS, as implemented through the ESA APPRISE Oncology Programme, is to mitigate the risk of decreased survival and/or poorer tumour outcomes.
“We believe it is critical that healthcare providers and their patients have a full and clear understanding of the risks associated with ESA therapy,” said Thomas Schaible, vice president, Medical Affairs, Centocor Ortho Biotech. “This programme will help provide information they can use to make the decision that is best for each individual patient.”
To support the implementation of the ESA APPRISE Oncology Programme, Centocor Ortho Biotech Products and Amgen will distribute a Dear Healthcare Provider letter introducing the program, providing the rationale, programme objectives, training and enrolment requirements and consequences for non-enrolment.