Procrit, Aranesp, Epogen Should Be Allowed for Cancer Patients, With Some Restrictions, FDA Panel SaysMar 13, 2008 | Parker Waichman LLP
An advisory panel has weighed in on the safety issues surrounding Procrit, Aranesp and Epogen, anemia drugs used to treat chemotherapy patients and others. While the Food and Drug Administration (FDA) advisory panel did not call on the agency to rescind the approval of Procrit, Aranesp and Epogen to treat cancer patients, it did recommend more limited restrictions on the drugs.
Procrit, Aranesp and Epogen are known as an erythropoiesis-stimulating agent (ESA). All are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech 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. When Procrit was first approved in 1989, the drug was touted as a treatment to lessen fatigue and improve quality of life among cancer and HIV patients with anemia. But since then Procrit has been forced to undergo five label changes, and the label now states that there was no evidence to back that claim.
Last Friday, Amgen and Johnson & Johnson announced that they would be including another black box warning on the drug's labels. The latest black box warned of the medications' association with increased tumor growth and shortened survival time in some cancer patients. The latest black box to be included on the labeling of Procrit, Aranesp and Epogen came on the heels of the PREPARE breast cancer study. That breast cancer study was one of 5 clinical trials that Amgen had agreed to after the safety of Aranesp was called into question. The new black box will cite information from PREPARE which showed patients had a higher risk of death on Aranesp. It also notes danger for patients with cervical cancer, based on results in December from a study called GOG-191.
Last March, the FDA also added a 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. This past November, that black box warning was modified to include more specific dosing information.
Today, the FDA convened a meeting of its cancer-drugs advisory committee to recommend what additional action the regulator should take in regards to Procrit, Aranesp and Epogen. The panel ultimately voted 13 to 1 in favor of allowing the continued sale of the ESAs for use in cancer patients undergoing chemotherapy. However, the panel voted 11 to 2 in recommending that the drugs not be used in cancer patients who are likely to be cured from their treatments, which suggests the drugs should only be used as part of a best-supportive care regimen for patients with advanced cancer or those expected to die from the cancer. The panel also voted 9 to 5 that the shouldn't be used in patients with breast cancer as well as patients with head and neck cancer. The FDA is not bound by the recommendations of its advisory panels, however, it usually does follow them.