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Procrit, Aranesp and Epogen to See More FDA Scrutiny After Two Studies Show Increased Tumor Growth in Some Cancer Patients Treated with ESAs

Jan 3, 2008 | Parker Waichman Alonso LLP

Two new studies suggest that Procrit, Aranesp and Epogen could carry more risks than first thought, prompting the Food & Drug Administration (FDA) to consider subjecting the anti-anemia drugs to even more regulatory action.  The FDA  already strengthened warnings on Procrit, Aranesp and Epogen twice last year and will hold another advisory panel meeting in the next few months to discuss the new studies.   The two new studies were not included in the most recent label update of the drugs on Nov. 8, the FDA said.

Aranesp, Epogen and Procrit are known as erythropoiesis-stimulating agents (ESAs).  All are made by Amgen, but Procrit is sold by Johnson &  Johnson under a licensing agreement.  ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. FDA-approved uses of ESAs are for the treatment of anemia in patients with chronic kidney failure; for cancer patients whose anemia is caused by chemotherapy; and for those infected with the human immunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT (zidovudine). ESAs are also approved to reduce the number of transfusions during and after major surgery.

Recently, several studies have linked the anemia drugs to cardiovascular problems and deaths. They have also been tied to worsening tumors when used in cancer patients. A year ago, FDA ordered a “black box” warning regarding cardiovascular problems and other safety issues posed by the drugs be included on their labels. In March, the FDA added another black box warning to the drugs’ labels cautioning doctors that the medications should be administered at the lowest dose possible in order to bring red blood cell counts to the lowest level necessary to avoid transfusions. Last month, that black box warning was modified to include more specific dosing information.

The latest ESA studies showed that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn't receive the anemia drug.  The agency said the two new studies, along with six that are included in the current drug labels "show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who did not receive this treatment.” The FDA said ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter or greater in the studies, which is higher than current dosing recommendations.