Femara (letrozole) of Novartis AG has received marketing authorization via the Mutual Recognition Procedure in Germany, for the treatment of postmenopausal women who have completed five years of standard adjuvant (post-surgery) tamoxifen therapy (extended adjuvant).
More than 40 countries, including the US, Switzerland and the United Kingdom, have issued approvals for Femara for the extended adjuvant indication. This approval is based on the landmark MA-17 study, an independent, internationally conducted trial that included more than 5,100 postmenopausal women which was coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario, and supported by Novartis. Initial results were published in the New England Journal of Medicine in October 2003, the release says.
The study showed that Femara reduced the risk of cancer coming back, or disease-free survival, by 42 per cent. This is particularly important because when breast cancer recurs, it very often has spread beyond the breast (metastatic disease), which can have serious consequences. Femara also reduced the chance of breast cancer returning to another part of the body, or distant metastases, by 39 per cent. The appearance of distant metastasis is a well-recognized predictor of mortality.
Henning Mouridsen, Rigshospitalet Department of Oncology, Copenhagen, Denmark said, "Femara is the only aromatase inhibitor proven beneficial after five years of standard tamoxifen treatment, providing a much needed therapy for women with early breast cancer, who, before now, had no options after tamoxifen."
Novartis is pursuing this indication in all member states of the EU. Following completion of the MRP process, EU member states are expected to use the final endorsed Summary of Product Characteristics to implement marketing authorizations locally.
Aromatase inhibitors, such as Femara, are recommended by the American Society of Clinical Oncology (ASCO) as the treatment of choice for postmenopausal women with early breast cancer, as cited in the "ASCO Technology Assessment on the Use of Aromatase Inhibitors as Adjuvant Therapy for Postmenopausal Women With Hormone Receptor Positive Breast Cancer: Status Report 2004."