C3 Submits Comment on ESAs to FDA Advisory Committee

By Nancy Roach, Chair, C3 Board of Directors

C3 has submitted comment to the Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC), recommending that FDA implement a Special Restriction Distribution Program for Erythropoiesis Stimulating Agents (ESAs), to maximize patient safety and ensure the rapid collection of patient information.

ESAs, better known under brand names, Procrit, Epogen and Aranesp, were approved by the Food and Drug Administration (FDA) to reduce the need for blood transfusions and have been used widely to aid with chemotherapy-induced anemia. Research results have indicated that higher doses of ESAs could actually cause a patient’s cancer to grow faster, and increase mortality, pointing out the need for future research to nail down the risk/benefit ratio of ESA use.

C3, in partnership with other advocacy organizations, has been working with FDA and ESA manufacturers (Amgen and Johnson & Johnson) to ensure that patients are helped, not harmed, by these supportive care drugs.

ODAC will be meeting on March 13, 2008 to discuss new research findings, future research plans and the current clinical situation. Carlea Bauman, C3 President, will speak during the open public hearing. In addition, C3 has submitted comments identifying questions such as:

• What is the plan for answering the question of whether ESAs have a tumor-promoting effect?
• What is the plan for answering the question of whether ESAs provide patient benefit when dosed according to the FDA label?
• What is the appropriate clinical use of ESAs pending the answers to these questions?

Ultimately, C3 recommends that ESA use be closely monitored, similar to the way that thalidomide use is monitored.

For additional information, see:

• www.ESAFacts.org presented by the Marti Nelson Cancer Foundation
• Briefing information from the May 10, 2007 ODAC meeting

Disclosure: C3 believes in fully disclosing sources of financial support, per our disclosure policy which can be viewed here. In 2006 and 2007, C3 received funding from Amgen in the form of a charitable donation. Since the May 2007 Oncology Drug Advisory Committee (ODAC) meeting, C3 has met with Amgen and Johnson & Johnson (J&J) to increase our understanding of these issues and express our concerns. J&J held a meeting on February 19, 2008 in Washington, DC, and paid the travel expenses of a C3 Board member so that she could attend the meeting.