Femara receives FDA nod for new indication

January 9, 2006

Novartis has been given the OK to market its aromatase inhibitor, Femara (letrozole), as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer. Approval of the new indication was based on results from the Breast International Group (BIG 1-98) study, which showed an additional 21% reduction in risk for cancer recurrence over tamoxifen therapy and a 27% reduction in the risk of cancer metastases to distant parts of the body. The drug was given a six-month priority review.