NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
August 5, 2008 • Volume 5 / Number 16 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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FDA Update

FDA Orders New Restrictions on ESA Use

The Food and Drug Administration (FDA) is requiring changes to the labels of three anti-anemia drugs - Aranesp (darbepoetin alfa), Procrit (epoetin alfa), and Epogen (epoetin alfa) - to revise their indications for cancer patients.

In a "complete response and safety labeling order" issued on July 30 to the drugs' manufacturer, Amgen, the FDA said the revised labeling must state that the medications should not be used in patients "when the anticipated outcome is cure." The FDA ordered the changes using new authorities granted to the agency last year that allow it to directly require labeling changes to address emerging safety issues.

The revised labels must also state that the drugs, called erythropoiesis-stimulating agents (ESAs), should not be used unless a patient's hemoglobin level dips below 10 g/dL; and the revision removes language indicating the drug can be safely used until patients' hemoglobin reaches 12 g/dL.

Amgen has 5 days to appeal the order or 15 days to submit a biologics license application supplement to the FDA with the revised labeling. The change was "consistent with our expectations," Amgen noted in a brief statement, adding, "We will soon be communicating the revised product labeling for ESAs to both physicians and patients."

NCI Cancer Bulletin Publication Break

The NCI Cancer Bulletin will not be published on September 2. We will resume our usual twice-monthly publication schedule on September 9.

The FDA did not require barring the drugs in patients with breast cancer or head and neck cancer, for which available data suggest the risk of serious adverse events may be greatest. At its March 2008 meeting, the FDA Oncologic Drugs Advisory Committee recommended instituting such a restriction. That meeting came on the heels of a meta-analysis of 51 phase III clinical trials, which found a 57 percent increased risk of venous thromboembolism (VTE), or blood clots, and a 10 percent increased mortality risk in cancer patients who were treated with ESAs.