Novartis’ Femara Shows To Be Superior To Tamoxifen

Novartis has published data for Femara (letrozole) following surgery, as an optimal treatment approach versus tamoxifen for postmenopausal women with early stage breast cancer (hormone-receptor positive), in the New England Journal of Medicine.

The data include an analysis from the Breast International Group (BIG) 1-98 trial. It evaluated patients taking either a sequence of Femara and tamoxifen for five years or Femara alone (as monotherapy) for five years. Also included is the update of the Monotherapy Arms Analysis (MAA) conducted ten years after initiation of the study, comparing five years of Femara alone versus five years of tamoxifen alone, following surgery (adjuvant setting). The BIG 1-98 trial was conducted by the International Breast Cancer Study Group (IBCSG).

Data from the study validates Femara alone for five years following hormone-receptor positive breast cancer surgery as an optimal treatment vs tamoxifen, in postmenopausal women.

Results show long-term superiority of Femara in improving disease-free survival (P=0.03) and reducing risk of distant metastases (P=0.05), as compared to tamoxifen.

Henning Mouridsen, professor of oncology, Copenhagen University Hospital and BIG 1-98 investigator, said: The BIG 1-98 study results suggest survival benefit with five years of letrozole therapy after surgery compared to tamoxifen for the same time period following surgery, confirming the benefit of initial use of letrozole in the adjuvant breast cancer setting.

Letrozole is the only aromatase inhibitor versus tamoxifen to demonstrate early and significant reduction in the risk of distant metastases, significant improvement in disease-free survival and this suggestion in overall survival benefit in primary breast cancer patients, he added.