Novartis' Femara approved in Germany following positive BIG 1-98 study data

Swiss drug major Novartis says that its breast cancer drug Femara (letrozole) has received regulatory approval in Germany for use as a treatment adjuvant in post menopausal women with hormone-sensitive early-breast cancer. The drug, which was originally developed by the firm Chiba Pharmaceuticals, which went on to become Novartis in a merger with fellow Swiss firm Sandoz in 1997, is a once-daily oral aromatase inhibitor designed to block estrogen in women with hormone-sensitive tumors.

German approval based on BIG 1-98 study

The German marketing approval decision is based on the results of the Breast International Group (BIG) 1-98 clinical trial which was a Phase III, randomized, double-blind program that compared adjuvant Femara with tamoxifen in around 8,000 women suffering with the disease. The results of the head-to head comparison, which were first published in the December 29, 2005, issue of the New England Journal of Medicine, showed that the Novartis drug reduced the risk of breast cancer an additional 19% (p=0.003) compared with tamoxifen.