February

FDA notifies health-care professionals of the results from a large clinical trial evaluating the use of an erythropoietic-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this trial, patients received either darbepoetin alfa(Drug information on darbepoetin alfa) (Aranesp) according to the approved dosing regimen or a placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions, compared to those treated with placebo.

FDA warns that the findings in the Aranesp trial also may apply to other ESAs (ie, epoetin alfa(Drug information on epoetin alfa), Epogen, Procrit) and, furthermore, that the findings show that treating anemic cancer patients NOT currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.

March

• FDA posts an alert: "Information for Health Care Professionals" to further inform prescribers and other health care professionals about important new safety findings. See: http://www.fda.gov/cder/drug/infopage/RHE/default.htm.

• Revised product labeling includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The boxed warning, the strongest warning for an FDA-approved product, advises physicians to use the lowest ESA dose that will gradually increase the hemoglobin level to a concentration sufficient to avoid the need for blood transfusions. Also, the boxed warning highlights the major safety risks for ESAs and important dosing information.

May

FDA convenes ODAC to discuss risks of ESAs, specifically Aranesp, Epogen, and Procrit, for use in the treatment of anemia due to cancer chemotherapy.

June

John K. Jenkins, MD, director of FDA's Office of New Drugs, Center for Drug Evaluation and Research, makes a statement in a Hearing before the House of Representatives' Committee on Ways and Means Subcommittee on Health. He presents background information on the drug approval process in general and FDA's regulatory history related to ESA products.

July

CMS issues final national coverage decision (NCD) on ESAs in cancer and related neoplastic conditions, limiting reimbursement to specific conditions.

August