Novartis seeks extended approval of breast cancer drug

If approved for this indication, Femara will become the only breast cancer treatment available to significantly reduce the risk of recurrence in the post-surgery setting as well as in extended post-surgery treatment following a course of tamoxifen.

The submissions are based on data from the Breast International Group (BIG) 1-98 study, a study that compared the safety and efficacy of adjuvant Femara vs. tamoxifen in more than 8,000 postmenopausal women with hormone receptor-positive early breast cancer.

The overall results indicated that Femara has significant advantages over tamoxifen (the current industry standard adjuvant drug) in the areas of prolonged disease-free survival, and reduction in the risk of cancer spreading to other parts of the body.

“Femara represents an important advance to help increase a woman’s chance of staying cancer free after initial treatment for early breast cancer,” said Dr Diane Young, vice president and global head of clinical development of Novartis Oncology. “The data filed today adds to the already substantial body of evidence supporting the use of Femara in breast cancer.”