'Femara represents an important advance to help increase a woman's chance of staying cancer-free after initial treatment for early breast cancer,' said Diane Young, MD, vice president and global head, Clinical Development, Novartis Oncology.

Once approved for this indication, the company says, Femara will become the only breast cancer treatment available to significantly reduce the risk of recurrence in the post-surgical setting.

Femara already is approved for use in post-menopausal women following a five-year course of tamoxifen -- the standard post-surgery treatment -- as well as in women whose breast cancer has metastasized.

Prolonged Disease-Free Survival

The marketing-authorization applications are backed by data from the Breast International Group (BIG) 1-98 study, a Phase III randomized, double-blind study that compares the safety and efficacy of post-surgical Femara vs. tamoxifen in more than 8,000 postmenopausal women with hormone receptor-positive early breast cancer.

The overall results of BIG 1-98 demonstrate that at a median follow-up of 26 months, Femara prolonged disease-free survival by reducing risk of recurrence by an additional 19% over the reduction offered by tamoxifen, Novartis reports.

Women who were treated with Femara experienced a 27% reduction in the risk that their cancer would spread to other parts of the body (distant metastases) compared with tamoxifen -- a clinically relevant finding, since women who develop distant metastases may be at greater risk of dying from their disease.

Femara also provided a 14% reduction in the risk of death, although this did not reach statistical significance, noted the company.

Risk of Distant Metastases Reduced

In two separate pre-planned subset analyses, Femara also reduced the risk of cancer returning by 29% among patients whose initial cancer had spread to the lymph nodes at the time of diagnosis (node-positive breast cancer), the company reports, and by 30% in those who had received chemotherapy -- two groups that are at increased risk of recurrence.

Additionally, the risk of distant metastases was reduced by more than 30% with Femara compared to tamoxifen in node-positive patients and in patients who received post-surgical chemotherapy.

"Femara represents an important advance to help increase a woman's chance of staying cancer-free after initial treatment for early breast cancer," said Diane Young, MD, vice president and global head, Clinical Development, Novartis Oncology.

"The data filed today add to the already substantial body of evidence supporting the use of Femara in breast cancer," Dr. Young added.