Femara Approved as First-Line Therapy After Breast Cancer

Approval based on comparative study with tamoxifen

FRIDAY, Dec. 30 (HealthDay News) -- The U.S. Food and Drug Administration announced on Thursday that is has approved letrozole (Femara) as a first-line therapy for postmenopausal women with hormone-sensitive breast cancer who have undergone surgery.

The FDA based approval on five-year data from the Breast International Group (BIG) 1-98 trial, which showed that Femara reduced the risk of breast cancer recurrence another 21% beyond tamoxifen. Femara also reduced the risk of distant metastasis an additional 27% more than tamoxifen.

The BIG 1-98 results are published in the Dec. 29 issue of the New England Journal of Medicine.

In women with lymph node involvement, Femara reduced risk of breast cancer recurrence by 29% and risk of distant metastases by 33% beyond tamoxifen's benefits. In women who had already undergone chemotherapy, Femara reduced risk of disease recurrence by 30% and risk of distant metastases by 31%.

"Femara has consistently demonstrated superiority against tamoxifen as first-line therapy in women with locally advanced or metastatic breast cancer, as well as in the adjuvant setting," said Diane Young, M.D., vice president and global head of the clinical development at Novartis Oncology, in a company statement. "In addition, Femara provides a notable benefit to patients who are at especially high risk of having their breast cancer return."

Femara is now the only drug in its class approved as first-line therapy for hormone-sensitive breast cancer.

More Information -- Novartis
Abstract
Full Text (subscription or payment may be required)

Physician's Briefing