FDA clamps down on ESA prescriptions

February 17, 2010

Concerned that erythropoiesis-stimulating agents may actually undo what chemotherapy has done, promoting tumor progression or recurrence and shortening overall survival, the FDA is clamping down on these products, marketed by Amgen as Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and by Centocor Ortho Biotech Products as Procrit (epoetin alfa).

Concerned that erythropoiesis-stimulating agents may actually undo what chemotherapy has done, promoting tumor progression or recurrence and shortening overall survival, the FDA is clamping down on these products, marketed by Amgen as Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and by Centocor Ortho Biotech Products as Procrit (epoetin alfa).

On Feb. 16, the agency approved a risk evaluation and mitigation strategy that limits the use of ESAs to healthcare providers who have enrolled and completed training in a program designed to minimize patient risks and optimize the benefits from ESAs. The program, called APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs), will be in place by the end of March. It was developed by Amgen and Centocor Ortho Biotech Products at the direction of the FDA. Amgen manufactures the ESA products. The FDA has also put Amgen in charge of overseeing and monitoring the program to ensure that providers are fully compliant.

Oncology professionals who prescribe ESAs must complete training in their use. The program requires that these professionals must also discuss with patients the risks of using ESAs before initiating a new course of therapy and must obtain a signed patient/healthcare professional form acknowledging these risks. Providers must re-enroll in the APPRISE program every three years. Only healthcare professionals enrolled in the program can prescribe ESAs for cancer patients.

More information about ESAs, the new strategy for mitigating risks accompanying their use, and the APPRISE Oncology Program is available on the FDA MedWatch website.