FDA Approves Femara as First-Line Therapy

EAST HANOVER, NJ—Novartis Oncology has announced that the FDA has approved Femara (letrozole tablets) for the first-line treatment of postmenopausal women with hormone-receptor-positive or hormone-receptor-unknown, locally advanced or metastatic breast cancer. Most postmenopausal women with advanced breast cancer fall into these tumor-receptor categories, the company said in a news release.

Letrozole, an aromatase inhibitor, is a once-a-day oral treatment that was first approved in 1997 for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Approval of the new indication followed a priority review by the FDA and a unanimous recommendation from the FDA’s Oncology Drugs Advisory Committee.

The recommendation was based on data from the largest single study ever to evaluate a hormonal therapy in this setting. Letrozole proved significantly more effective than tamoxifen (Nolvadex) in multiple efficacy endpoints.