by Mary DeLucco
The Food and Drug Administration (FDA) announced in January that it is reviewing two new studies that provide further evidence that the anemia drugs known as erythropoiesis-stimulating agents (ESAs) could be dangerous to breast cancer patients who receive them for treatment of chemotherapy-induced anemia.
The studies showed that patients with breast or advanced cervical cancers who received Aranesp, Epogen, or Procrit died sooner or had more rapid tumor growth than similar patients who did not receive the anemia drugs.
The new studies arrived on the heels of six other studies—with similar findings—that prompted the FDA last November to order stronger label warnings about the use of ESAs in cancer patients.
The FDA says that taken together, 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.“This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer,” said FDA chief medical officer Janet Woodcock.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet in March to review the new data and assess the risks of using ESAs.