Femara letrozole: Phase III data; sNDA under review; marketed as second-line therapy

In a Phase III trial of 900 postmenopausal women with locally advanced, metastatic or recurrent breast cancer, Femara delayed disease progression by 9.4 months versus 6 months with tamoxifen, and gave a 30 percent overall tumor response rate versus 20 percent with tamoxifen. In a separate Phase III trial of 324 patients, Femara treatment for 4 months prior to surgery gave a 55 percent clinical response rate versus 36 percent with tamoxifen. ...