2007: A tumultuous year for erythropoietic-stimulating agents
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 (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, 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.
• 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.
FDA convenes ODAC to discuss risks of ESAs, specifically Aranesp, Epogen, and Procrit, for use in the treatment of anemia due to cancer chemotherapy.
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.
CMS issues final national coverage decision (NCD) on ESAs in cancer and related neoplastic conditions, limiting reimbursement to specific conditions.
• ASCO requests CMS reopen the NCD and delay effective date.
• US Oncology supports ASCO concerns; requests CMS to reopen NCD.
• Community Oncology Alliance requests CMS reexamine NCD.
• ASCO sends a letter to Michael Leavitt, Secretary of Health and Human Services (HHS), expressing concern about the NCD and outlining the conflicts between the CMS coverage decision and the FDA-approved label for ESAs.
• Rep. Anna Eshoo (D-Calif) and Rep. Mike Rogers (R-Mich) introduce H.J.RES.54, a Joint Resolution disapproving CMS's national coverage decision on the use of ESAs in cancer and related neoplastic conditions. In addition, Rep. Stephen Cohen (D-Tenn) introduces resolution H.RES.681 urging CMS to reconsider its coverage decision on ESAs and consult with members of the oncology community to make appropriate revisions to its policy.
• CMS responds to ASCO, asking for new evidence.
• ASH/ASCO issues updated guideline on ESAs in chemotherapy-related anemia.
• FDA agrees with CMS in limiting reimbursement for ESA products.
• Dr. Peter Ellis, of the University of Pittsburgh Medical Center Cancer Centers, chairs a meeting of approximately 50 leading oncologists from across the country to discuss concerns and reach a consensus on the NCD for ESAs in cancer treatment. The group issues a statement asking CMS to reconsider the NCD and to alter its decision to reflect the ASCO/ASH guideline on ESA use.