FDA Approves Evista To Reduce Invasive Breast Cancer Risk In Postmenopausal Women With Osteoporosis

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Main Category: Breast Cancer
Also Included In: Bones / Orthopaedics;  Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 15 Sep 2007 - 0:00 PDT

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Evista (raloxifene HCl), a drug aimed at reducing invasive breast cancer risk for both postmenopausal women with osteoporosis and postmenopausal women with a invasive breast cancer risk has been approved by the US Food and Drug Administration (FDA) for both groups of women.

Gwen Krivi, Ph.D., VP, Lilly Research Laboratories "The FDA's decision marks a major milestone. 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. Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."

Evista, which was recently classified as an estrogen agonist/antagonist by the FDA, is a SERM (selective estrogen receptor modulator). It already exists for the prevention/treatment of osteoporosis in postmenopausal women. Two months ago the Oncologic Drugs Advisory Committee (ODAC) voeted for the two new uses to be approved - the FDA, as it did on this occasion, usually goes along with what the committee (advisory panel) recommends.

The decision to approve Evista for this new indication, says makers Eli Lilly, was based on data submitted last year in an NDA (new drug application), which evaluated clinical results from about 37,000 women over a period of ten years; all the women were postmenopausal.

A recent trial found that Evista does not raise the incidence of stroke, but does the incidence of death due to stroke. A boxed warning now says "women with an active or past history of venous thromboembolism should not take EVISTA.. Women at risk for stroke should receive EVISTA only after evaluating the risk-benefit balance with their healthcare providers."

Dr. Lawrence Wickerham, M.D., associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), associate professor of human oncology at Drexel University School of Medicine, said "Thousands of women each year are diagnosed with invasive breast cancer. Today's (14th September) 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."

According to the American Cancer Society, about 180,000 women are diagnosed with invasive breast cancer each year.

-- Important Safety Information About EVISTA®

Important Limitations of Use for Breast Cancer Risk Reduction

EVISTA is indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. EVISTA does not treat existing breast cancer, reduce the risk of getting breast cancer again or reduce the risk of all forms of breast cancer.

http://www.evista.com

Written by: Christian Nordqvist


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