The US Food and Drug Administration has granted priority review to Novartis' Femara (letrozole) in the adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor-positive early breast cancer.
According to a company release, Novartis asked for consideration for priority review based on enhanced efficacy in high risk subgroups for which existing therapies have not demonstrated benefit. Specifically, Femara showed significantly improved efficacy compared with tamoxifen in women with node-positive disease and those who received chemotherapy treatment. Femara also demonstrated a significantly reduced risk of distant metastases compared with tamoxifen.
If approved for this new indication, Femara will become the only breast cancer treatment approved in the US to significantly reduce the risk of recurrence for both the adjuvant setting and in extended adjuvant treatment following standard tamoxifen therapy. The supplemental new drug application for use of Femara in the adjuvant setting was submitted in June 2005. Novartis has submitted marketing applications for this indication globally, said the release.
The FDA submission is based on data from the Breast International Group (BIG) 1-98 study, a Phase III, randomized, double-blind study that compared the safety and efficacy of adjuvant Femara vs. tamoxifen in more than 8,000 postmenopausal women with hormone receptor-positive early breast cancer.
Femara is a leading once-a-day oral aromatase inhibitor currently available in more than 90 countries worldwide. Femara is approved for extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant tamoxifen therapy in 57 countries worldwide, including Europe as well as the United States.