Novartis’ antitumour agent, Femara (letrozole), has been granted US Food and Drug Administration priority review for a new label: to treat post-menopausal women with early breast cancer in the post-surgery setting. The Swiss giant filed for this indication in June across global markets, but winning the priority review status means it will get a decision on approvability in the world’s largest pharmaceutical market by the end of the year.
The application includes data from an 8,000 patient head-to-head study - dubbed BIG 1-98 - showing Femara was more effective than tamoxifen in helping women stay free of the disease [[27/01/05d]]. At just over two years, results showed Femara cut the risk of the disease recurring by an additional 19% over that offered by tamoxifen. Furthermore, women who were treated with Femara experienced a 27% reduction in the risk of cancer spreading to other parts of the body compared with tamoxifen, alongside a 14% reduction in the risk of death, although this did not reach statistical significance.
If approved for this new label, Novartis says “Femara will become the only breast cancer treatment approved in the USA to significantly reduce the risk of recurrence for both the adjuvant setting and in extended adjuvant treatment following tamoxifen therapy.”