Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-43 Jason Brodsky: 301-827-6242
September 16, 1999
Consumer Inquiries: 888-INFO-FDA
Epirubicin is a member of the anthracycline class of anti-cancer medications, which are believed to work by interfering with a number of biochemical and biological functions within cancer cells -- though their precise mechanism of action is not completely understood. These drugs are commonly used in combination with other medications to treat patients with cancer, slowing or halting the progression of cancer in some patients, and prolonging the lives of patients in some settings.
FDA based its decision on the results of two long-term, open-label clinical studies that enrolled approximately 1,200 patients. The findings showed significant lengthening of the time without a relapse of the disease (reoccurrence of tumor) and increased 5-year overall survival.
The first study compared an epirubicin-containing combination to a standard combination. Patients in the epirubicin group had a significantly increased 5-year survival without relapse rate (62% versus 53%) and increased 5-year overall survival (77% versus 70%) compared to those given standard therapy.
The second study compared a higher dose epirubicin- containing regimen to a lower dose epirubicin-containing regimen. Patients treated with the higher-dose epirubicin regimen had significantly greater 5-year survival without relapse rate (65% versus 52%) and 5-year overall survival (76% versus 65%) than patients given the lower-dose epirubicin regimen.
Adverse effects associated with the use of the drug include nausea, vomiting, diarrhea, stomatitis and hair loss. Before initiating therapy with epirubicin, patients should be informed that there is a risk of irreversible damage to the heart muscle associated with the drug. For women who receive epirubicin as adjuvant therapy, there is a slightly increased risk of treatment-related leukemia. Epirubicin may cause harm to the fetus if given to a pregnant woman. The drug may also cause premature menopause in premenopausal women. Men undergoing treatment with epirubicin should be advised to use effective contraceptive methods because therapy with the drug can induce chromosomal damage in sperm.
On June 7 of this year, the FDA's Oncologic Drugs Advisory Committee recommended approval of epirubicin for use as a component of adjuvant (post-surgical) combination therapy of breast cancer patients in whom the disease has spread to the lymph nodes under the arm.
The drug will be marketed under the trade name Ellence by its manufacturer, Pharmacia & Upjohn of Peapack, NJ.