The approval allows Evista to be used to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. The company has evaluated clinical results from approximately 37,000 postmenopausal women for 10 years.
Evista, a selective estrogen receptor modulator or SERM (recently classified by the FDA as an estrogen agonist/antagonist), is already approved for the prevention and treatment of osteoporosis in postmenopausal women.
Earlier this year, the osteoporosis label for Evista was updated to include safety information from the Raloxifene Use for The Heart (RUTH) trial, which evaluated postmenopausal women with known or at increased risk for coronary disease taking Evista. This trial found no increase in the incidence of stroke, but an increase in the incidence of death due to stroke.
Since the new label for Evista includes new uses and an expanded patient population, Indianapolis, Ind.-based Lilly worked with the FDA to revise the package insert, which will now include a boxed warning. The warning highlights information already included in the contraindications and warnings and precautions sections of the prior label. It emphasizes that women with an active or past history of venous thromboembolism should not take Evista, and that women at risk for stroke should receive Evista only after evaluating the risk-benefit balance with their healthcare providers.
The so-called black-box warning does not preclude the company from conducting direct-to-consumer advertising, which includes a consumer website at evista.com, says Eli Lilly spokesperson Sharon Corbitt. She declined to discuss what other DTC marketing the company has planned. "Thousands of women each year are diagnosed with invasive breast cancer," says Dr. Lawrence Wickerham, associate chairman of the National Surgical Adjuvant Breast and Bowel Project and associate professor of human oncology at Drexel University School of Medicine, in a release. "Approval of Evista for these new uses gives postmenopausal women at risk for this disease an important new treatment option that allows them to take a proactive approach to reducing their risk."
While the exact causes of breast cancer are unknown, certain risk factors are linked to the disease--including age, family history, personal history of breast cancer, genetics and lifestyle factors. The increased incidence of breast cancer as women age is notable, as nearly eight out of 10 breast cancers are found in women age 50 and older. The American Cancer Society estimates that approximately 180,000 women are diagnosed with invasive breast cancer each year.
Competing osteoporosis drugs include Merck & Co Inc.'s Fosamax, and Roche Holding AG's and GlaxoSmithKline Plc's Boniva.
Not everyone agrees with or supports the FDA decision. At least two women's health advocacy groups oppose the move. "Approval [of Evista] allows advertising, and the advertising, almost by definition, is going to be misleading," Cindy Pearson, executive director of the National Women's Health Network, told USA Today. "It's going to imply that there's a bigger net benefit than we know to be true."