Osteoporosis drug Evista can prevent breast cancer
pharmafile | April 26, 2006 | News story | Sales and Marketing |
A new study of Lilly's Evista suggests it could help prevent postmenopausal women developing breast cancer.
A major new study of the drug shows it to be effective in reducing the risk of women developing invasive breast cancer by about 50%, about the same as established breast cancer drug tamoxifen.
This makes the drug as effective as tamoxifen in preventing the cancer, but the trial shows Evista caused fewer serious side effects.
Remarkably, Evista (raloxifene) is currently used for a completely separate condition, osteoporosis, but researchers now believe it could be a major advance in the prevention of breast cancer.
The US-based trial was co-ordinated by the National Surgical Adjuvant Breast and Bowel Project (NSABP), a network of cancer research professionals, and is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health.
"This optimistic news from STAR is a significant step in breast cancer prevention," said the NCI's John Niederhuber. "These results, once again, demonstrate the critical importance of clinical trials in our efforts to establish evidence-based practices."
The ability of tamoxifen to prevent breast cancer has been established for a number of years, but Evista has now shown a number of significant advantages over the older treatment.
The group taking Evista developed 36% fewer uterine cancers and 29% fewer blood clots than women given tamoxifen. Uterine cancers, especially endometrial cancers, are a rare but serious side effect of tamoxifen. The drug is also known to cause the development of cataracts in patients.
Evista is not completely free of such side effects – like tamoxifen, it is also known to increase a woman's risk of blood clots.
Nearly 20,000 postmenopausal women took part in the study and were at least 35 years old. All participants had an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth.
"Although no drugs are without side effects, tamoxifen and raloxifene are vital options for women who are at increased risk of breast cancer and want to take action," said Leslie Ford, associate director for clinical research in NCI's Division of Cancer Prevention. "For many women, raloxifene's benefits will outweigh its risks in a way that tamoxifen's benefits do not."
Evista is already Lilly's fourth biggest selling drug, earning just over $1 billion in 2005.
Lilly says it plans to submit the drug to regulators later this year, and analysts say an approval would help boost sales by 15% within three years.
