The U.S. Food and Drug Administration (FDA) has approved a new drug for fighting recurrence of breast cancer. The approval came as results of a study of the drug, Femara, were reported in the December 29, 2005 issue of the New England Journal of Medicine. The study found the drug, already used for late-stage breast cancer, was also effective in keeping cancer from recurring in early-stage cases.
Femara, or letrozole, is a member of the drug class known as aromatase inhibitors, which stop the growth of cancerous tumors by blocking the body’s production of estrogen. Femara, by Swiss pharmaceutical maker Novartis, was shown to be more effective than the most popularly prescribed drug, tamoxifen, while avoiding certain serious side effects experienced with tamoxifen, such as endometrial cancer and blood clots.
The FDA approval was based on results of the Breast International Group (BIG) 1-98 study, which compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy after surgery in postmenopausal women with hormone-sensitive early breast cancer.
Femara reduced the risk of breast cancer recurrence by an additional 21 percent over the reduction offered by tamoxifen. Also, the study showed, patients taking Femara showed a 27 percent reduction in the risk of the cancer spreading to distant parts of the body. The study involved 8,000 women with breast cancer in 27 countries.
More than 200,000 American women were diagnosed with breast cancer last year, according to American Cancer Society data.
Use Is Restricted
Femara is already widely available in Scotland. It was licensed in December by the Medicines and Healthcare Products Regulatory Agency, an agency of the National Health Service, for use in the U.K., but it is currently offered only to patients who cannot tolerate tamoxifen. The National Health Service is not expected to approve wider use for the drug until late this year, according to a December 29 BBC News report.
Patient advocates in the U.K. are calling for the National Institute for Health and Clinical Excellence (NICE), the independent organization responsible for providing national guidance on health, and other health authorities to fast-track authorization of the drug for breast cancer patients.
“Femara is technically available to clinicians to prescribe,” explains Jill Morrell of CancerBACUP, a U.K. cancer information source and patient advocacy group. “However, the body that issues guidance on how clinically and economically effective a drug is will not issue guidance until November 2006. In practice, clinicians wait for NICE to issue guidance before prescribing [a drug]. We are campaigning for the Department of Health and NICE to speed up the time it takes to make a drug routinely available on the NHS.”
Potentially Fatal Delays
The red tape of government bureaucracy may have dire results, experts warn.
“Genetic tests will and are matching patients with medicines that work best with their particular disease pathway more quickly and accurately than a bureaucracy can do sifting through old one-size-fits-all studies,” said Robert Goldberg, Ph.D., senior fellow at the New York City-based Manhattan Institute’s Center for Medical Progress. “Under government-run health [systems], the innovation gap between patient and disease is turning into a valley of death in an age of personalized medicine.”
Susan Konig ([email protected]) is managing editor of Health Care News.