The approval covers postmenopausal women with osteoporosis and postmenopausal women at high risk of invasive breast cancer, according to Eli Lilly.
"Today's action provides an important new option for women at heightened risk of breast cancer," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman. Women should talk with their health-care provider about whether the drug is right for them."
"For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns -- osteoporosis and invasive breast cancer," Gwen Krivi, vice president of Lilly Research Laboratories, said in a prepared statement. "Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."
On July 24, the FDA's Oncologic Drugs Advisory Committee voted 8 to 6 to recommended approval of Evista (raloxifene) for postmenopausal women with osteoporosis, and voted 10 to 4 to recommended it for postmenopausal women at high risk for breast cancer.
The approval of Evista, which studies have shown can produce potentially dangerous side effects such as blood clots and stroke, would give women a valuable option in fighting breast cancer, one panel member said following the July vote.
"We've got a drug out there, tamoxifen, with its advantages and its possible flaws,'' David Harrington, chairman of the biostatistics department at Dana-Farber Cancer Institute in Boston said. "Women at high risk for breast cancer -- it would be very nice to have a second option for them," he said.
However, not everyone agreed with the panel's recommendation.
"The reason that we are concerned and will continue to be concerned about it [Evista] is the history of every drug that's ever been used to 'prevent breast cancer,' " Barbara Brenner, executive director of Breast Cancer Action said.
Brenner noted that even women who do take these drugs can get breast cancer.
"In addition, the number of women who are going to be exposed to a drug with very serious and potentially fatal side effects in the interest of reducing very small numbers of breast cancer is very frightening to us," Brenner said. "We would like to see this disease prevented but not at the risk to women's health."
While Evista has been shown to reduce the risk of breast cancer among postmenopausal women with osteoporosis, and postmenopausal women at high risk for breast cancer, it also increases their risks for blood clots and stroke.
In the Raloxifene Use for The Heart (RUTH) trial -- which included more than 10,000 postmenopausal women -- researchers found that, compared with a placebo, Evista had no significant effect on the risk of first-time coronary events.
At the same time, it reduced the risk of invasive breast cancer by 44 percent -- meaning about 1.2 fewer cases of cancer per 1,000 women treated with raloxifene per year.
However, while the study showed no significant difference in deaths from any cause, or total deaths from stroke, women in the raloxifene group did have a 55 percent increased risk of fatal stroke (0.7 excess fatal strokes per 1,000 women treated per year) and a 44 percent increased risk of blood clots (1.2 more cases per women treated per year), according to a report published in July 2006 in the New England Journal of Medicine.
Women should learn what this drug can and cannot do for them and make an informed choice, Brenner said. "Do not depend on the FDA to do that for you."
However, Dr. Len Lichtenfeld, the deputy chief medical officer at the American Cancer Society, backed the FDA panel's July recommendation.
"The drug has been demonstrated to have benefit in preventing breast cancer in women at increased risk," Lichtenfeld said following the July advisory panel vote. "The drug should be approved. That would then give us two options, and Evista may have a better safety profile than tamoxifen," he said.
In the STAR (Study of Tamoxifen and Raloxifene) trial published in June 2006, almost 20,000 postmenopausal women at increased risk for breast cancer took either tamoxifen or Evista daily for five years. Tamoxifen is the only drug approved for reducing breast cancer risk.
That trial found that both drugs reduced the risk of breast cancer by about 50 percent -- from eight cases per 1,000 women per year to about four per 1,000 women per year.
However, Evista was not as effective in preventing non-invasive breast cancers as tamoxifen, according to a report, which appeared in the Journal of the American Medical Association.
"Both Evista and tamoxifen have risks," Lichtenfeld acknowledged. "But Evista has been used widely for the treatment of osteoporosis, so physicians are comfortable with that. While this is not a perfect answer to the increased risk of breast cancer, it is the best answer we have right now."
In 2005, Eli Lilly pleaded guilty and paid a $36 million fine for illegally promoting Evista to reduce the risk of breast cancer, a violation of the Food, Drug, and Cosmetic Act.