Risks of Anemia Drugs in Chemotherapy Patients Are Bolstered

By Peggy Peck
ROCKVILLE, Md., Jan. 3 -- More research has strengthened an association between erythropoiesis-stimulating agents (ESAs) and an increased risk of mortality when the drugs are used for chemotherapy-induced anemia, the FDA said today.
The new data came from two studies of women with breast cancer or advanced cervical cancer, research that had not been included when the FDA ordered a label change two months ago about excess mortality and/or rapid tumor growth with ESAs. This warning was on the basis of six other studies.
In today's statement, the FDA said that "all eight studies 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. In all of these recent studies, ESAs were administered in an attempt to achieve a hemoglobin level of 12 g/dL or greater, although many patients did not reach that level."
The FDA said that on Nov. 30, Amgen, manufacturer of the three ESAs -- Aranesp, Epogen, and Procrit -- provided the agency with information from the 733-patient PREPARE study of women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14% of the patients given Aranesp to treat their anemia had died, compared with 9.8% who did not receive the drug. Tumor growth was also faster in patients given Aranesp.
On Dec. 4, Amgen informed the FDA of the results of a study by the National Cancer Institute's Gynecologic Oncology Group of patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were given Procrit to maintain hemoglobin levels above 12 g/dL or transfusions as needed. After three years, 66% of the patients who did not take Procrit were alive and free of cancer growth compared with 58% given the drug.
Janet Woodcock, M.D., the FDA's chief medical officer and acting director of the Center for Drug Evaluation and Research, said the new information does not require immediate action, but does underscore "the safety concerns regarding use of ESAs in patients with cancer."
She said the FDA would discuss the new data at a planned advisory committee meeting on ESA safety "in the next few months."
Meanwhile, she said the FDA would continue to review available data and "may take additional action." She said physicians should "review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients."
Amgen is based in Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J., a subsidiary of Johnson & Johnson.