Novartis has announced the U.S. regulatory approval of Femara (letrozole) in a new indication as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer.

The approval was based on results of the BIG 1-98 study, which were published in the New England Journal of Medicine. BIG 1-98 compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy after surgery in postmenopausal women with hormone-sensitive early breast cancer.

Femara reduced the risk of breast cancer returning by an additional 21 percent over the reduction offered by tamoxifen. Further, patients taking Femara showed a 27 percent reduction in the risk of the cancer spreading to distant parts of the body. Women whose disease does spread to other sites (metastases) may be at greater risk of dying from their disease.