Novartis has announced that Femara (letrozole) has received approval in Germany for use after surgery in postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting). This is the first major European market approval for this additional indication under the European mutual recognition procedure.
The approval was based on results from the BIG 1-98 study, a comparison of Femara versus tamoxifen, which demonstrated that Femara reduced the risk of breast cancer recurrence by an additional 19 percent. The benefit of Femara was most evident in women with a higher risk of their breast cancer coming back, i.e. those whose breast cancer has already spread to the lymph nodes (node-positive) and/or those who have received chemotherapy.