ASCO Policy Alert Published

The Oncologic Drugs Advisory Committee to the FDA met yesterday to discuss the use of erythropoiesis stimulating agents (ESAs). The Committee addressed many different aspects of ESA use, including new studies that have been released since its last meeting in May of 2007. Below is a summary of the Committee's key recommendations. ASCO has also prepared a more in-depth summary including an outline of each question the Committee addressed. In summary, the ODAC recommended:

Allowing ESAs to continue to be marketed for the chemotherapy-induced anemia (CIA) indication.

Not to restrict use only to patients with small cell lung cancer.

To modify the current indication to include a statement that ESA use is not indicated for patients receiving potentially curative treatments.

To modify the current indication to include a statement that ESA use is not indicated for patients with metastatic breast and/or head and neck cancers.[1]

That the FDA require the implementation of a signed informed consent/patient agreement for the treatment of CIA, but voted against the FDA mandating a restricted distribution system for oncology patients receiving ESAs.

A representative for ASCO and the American Society of Hematology (ASH) described the recent changes to the ASCO/ASH ESA guideline, and described plans for further updates focusing on providing tools for enhanced physician-patient communication regarding use of ESAs.

ODAC is an advisory committee to the FDA. We do not yet know which of these recommendations FDA will accept or when and how they will be implemented. ASCO will keep you apprised of additional developments.

[1] The original question did not include the word "metastatic"; the Committee asked that it be added, following the vote on potentially curative treatments.