Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Amgen and Centocor Ortho Biotech have said that the FDA has approved the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa).
Subscribe to our email newsletter
The ESA APPRISE Oncology program will be launched on March 24, 2010. Direct patient registration or approval prior to ESA administration is not required through the ESA APPRISE Oncology program.
The goal of the ESA REMS is to support informed decisions between patients and their healthcare providers who are considering treatment with Aranesp, Epogen or Procrit 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 Program, is to mitigate the risk of decreased survival and/or poorer tumor outcomes, the company said.
Roger Perlmutter, executive vice president of research and development at Amgen, said: “The ESA REMS represents our continued commitment to patient education and safety. This program supports a thoughtful dialogue between healthcare providers and patients when considering ESA treatment.”
To support the implementation of the ESA APPRISE Oncology program, Amgen and Centocor Ortho Biotech Products will distribute a dear healthcare provider letter introducing the program, providing the rationale, program objectives, training and enrollment requirements and consequences for non-enrollment.