An expert panel that advises the US Food and Drug Administration (FDA) has voted to recommend the osteoporosis drug Evista (Eli Lilly) be approved for use in preventing invasive breast in postmenopausal women.
Evista (chemical name raloxifene hydrochloride) is a prescription drug that prevents and treats osteoporosis in postmenopausal women. It is a selective estrogen receptor modulator (SERM) which the FDA has recently classified as an estrogen agonist/antagonist. Over 52 million Evista prescriptions have been filled since the FDA approved it in 1997.
If approved, Evista will give postmenopausal women at high risk of developing breast cancer an alternative to the anti-estrogen drug tamoxifen.
The FDA’s Oncologic Drugs Advisory Committee voted to recommend the FDA approve Evista as a prescription drug for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis (vote was 8 to 6 in favour) and postmenopausal women at high risk of developing breast cancer (vote was 10 to 4 in favour).
The FDA does not have to follow advisory committee recommendations, but it usually does.
According to Eli Lilly, the company submitted four studies (covering 37,000 postmenopausal women followed for nearly ten years) as part of the evidence for the new drug approval application. Between them the four studies covered three separate groups of postmenopausal women who:
- Were at increased risk of developing breast cancer. They were participating in the Study of Tamoxifen and Raloxifene (STAR) trial, which was sponsored by the National Cancer Institute (NCI) and coordinated by the National Surgical Adjuvant Breast and Bowel Project (NSABP).
- Had known or were at increased risk of coronary heart disease. They were participating in the Raloxifene Use for The Heart (RUTH) trial.
- Had osteoporosis. They were participating in the Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) trials.
Evista is not without risks. The panel’s recommendation is based on weighing up the benefits against the known risks, and as for all medication, caution should be exercised when considering the drug in the light of potential contra-indications.
Evista is not recommended for women who are pregnant or breast feeding, or who have liver or kidney problems or are under treatment for blood clots or have a history of them. Being immobile for long periods adds to the risk of blood clots developing in the veins. Usage of the drug should be discontinued during these periods.
In trials the drug did not affect the risk of heart attack, stroke, cardiovascular death or overall death, but in a study of postmenopausal women at high risk of cardiovascular disease who were taking Evista, there was an increase in the rate of death due to stroke, although incidence of stroke itself was not changed.
Women with a history of stroke or associated risk factors, smoking, or irregular heart beat (atrial fibrillation) should discuss the risks as well as the benefits of taking Evista with their doctor before taking out a prescription.
The most common side effects (occurring 2 per cent more frequently than placebo in trials) of Evista are hot flashes, cramps in the legs, peripheral edema (swelling in the lower limbs), flu syndrome, sweating and arthralgia (painful joints).
A prescription for Evista comprises 60 mg tablets taken by mouth once a day. The current label carries the FDA warning that it should not be used for the primary or secondary prevention of cardiovascular disease and neither should it be used for premenopausal women. And it should not be used in conjunction with estrogen.
A number of breast cancer groups were not happy with the news. According to a report in WebMD, the Breast Cancer Coalition said the government should be concentrating effort on finding the causes of breast cancer rather than approving drugs “with relatively small benefits”.
Breast cancer is the most common cancer in women, second to skin cancer, and it is the leading cause of cancer death in women after lung cancer.
According to the American Cancer Society, 178,000 American women will be diagnosed with invasive breast cancer this year and nearly 40,500 will die from it. There are over 2 million women living with breast cancer in the US today who have received treatment for it.
The risk of a woman developing invasive breast cancer during her lifetime is about 1 in 8, and the chance of dying from it is about 1 in 33.
Men get breast cancer too. About 2,000 American men will be diagnosed with it and 450 will die from it this year according to the National Cancer Institute.
The causes of breast cancer are yet to be discovered, but there are known risks factors. These include age, family history, having had it before, genetics, lifestyle and race. Age is one of the biggest risk factors. Nearly 80 per cent of breast cancers occur in women over 50 who are past the menopause.
There is good news too: deaths due to breast cancer are going down. Earlier diagnosis and better treatments are probably the main reasons why.
Written by: Catharine Paddock