Novartis has won approval in the UK to market its breast cancer drug Femara for use immediately after surgery in women with early-stage disease.
The UK is the first country in Europe to approve the new indication, which makes Femara (letrozole) the only aromatase inhibitor cleared for use across the entire breast cancer spectrum – before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.
The new indication has yet to be approved in the USA, although the Food and Drug Administration has fast-tracked Novartis marketing application and is due to deliver a verdict by the end of the year.
Femara has been shown to significantly reduce recurrence of disease when given after surgery to post-menopausal women to women with invasive breast cancer, according to the results of the BIG1-98 trial.
Data showed that compared to those women taking tamoxifen, Femara significantly improved disease free survival by 19% in all women taking it and by 29% in high risk women whose cancer had spread to the lymph nodes. It also significantly reduced breast cancer recurrence by 28% in patients who had previously received chemotherapy and reduced overall risk of cancer spreading to other parts of the body by 27%.
This profile should aid Femara as it competes with the other main aromatase inhibitors, AstraZeneca’s Arimidex (anastrozole) and Pfizer’s Aromasin (exemestane, and add to the sales momentum behind Novartis’ drug, which saw sales in the third quarter of this year climb 44% to $390 million dollars, making it the fastest-growing product in the firm’s oncology franchise.