FDA Approves Femara(R) (Letrozole Tablets) for Advanced Breast Cancer

Thursday, January 11th 2001, 12:00 am

By: News On 6

Novartis Oncology announces that the U.S. Food and Drug Administration has approved Femara(R) (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.

Approval of the new indication followed a priority review by the FDA and a unanimous recommendation from the FDA's Oncologic Drugs Advisory Committee. The recommendation was based on data from the largest single study ever to evaluate a hormonal therapy in this setting. The study found that Femara was significantly more effective than tamoxifen in multiple efficacy endpoints. Tamoxifen has traditionally been the standard of therapy for this indication.

The Phase III trial on which the FDA based its decision was a head-to-head, randomized, double-blind multi-center trial comparing the use of Femara versus tamoxifen in more than 900 postmenopausal women who had locally advanced (stage IIIB) disease, metastatic breast cancer, or recurrences not amenable to treatment with surgery or radiotherapy. The study demonstrated that Femara delays progression of advanced breast cancer for 9.4 months, as compared to 6.0 months for tamoxifen.

Femara, an aromatase inhibitor, is a once-a-day oral treatment that was first approved for marketing in 1997 for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. In July 2000, Novartis submitted a supplemental New Drug Application (sNDA) for first-line therapy in advanced breast cancer and, in August 2000, the sNDA received a priority review designation from the FDA.