Novartis has got a green light in Germany to extend the labelling for Femara to include post-surgery use in postmenopausal women with hormone-sensitive early breast cancer.
The Swiss drugmaker said this is the first market approval for this additional indication in continental Europe, and follows earlier clearances in the US, UK and in Japan. Further approvals are expected in other European countries in the near future.
The new indication is expected to boost Femara (letrozole) in its competitive tussle with other drugs in the aromatase inhibitor class, and especially arch rival Arimidex (anastrozole) from AstraZeneca.
The new indication makes Femara 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 – and Novartis believes this will make it attractive to oncologists because they will be able to keep their patients on the same drug throughout the course of the disease.
Critically, it also means Femara can now vie directly with Arimidex for use in early-stage breast cancer patients. Armidex is already approved for use in this setting, and has had the advantage of being used ahead of its rival.
This has been reflected in product sales: Femara brought in $536 million last year, while Arimidex sales were $1.18 billion. Novartis believes that Femara can now gather sales momentum and grow to become a blockbuster brand.
Meanwhile, Novartis is conducting a major head-to-head trial of Femara and Arimidex in an attempt to show that its drug is superior and win market share from its rival. The FACE study will enroll 4,000 women with early breast cancer.