Novartis has received the US regulatory approval of Femara (letrozole) in a new indication as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer.

The US approval was based on results of the Breast International Group (BIG 1-98) study. BIG 1-98 compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy after surgery (adjuvant setting) in postmenopausal women with hormone- sensitive early breast cancer. The study included an analysis of disease-free survival in patients treated for a median of 24 months and followed for a median of 26 months. The BIG 1-98 study is ongoing, and further analyses on safety and efficacy are planned, states a company release.

Femara reduced the risk of breast cancer returning by an additional 21% over the reduction offered by tamoxifen. Further, patients taking Femara showed a 27% reduction in the risk of the cancer spreading to distant parts of the body. While no survival advantage has been demonstrated, this is clinically relevant because women whose disease does spread to other sites (metastases) may be at greater risk of dying from their disease.

In addition to the overall findings, Femara demonstrated its greatest benefit in two groups of women at increased risk of recurrence. Femara reduced this risk by 29% in women whose breast cancer had already spread to the lymph nodes at the time of diagnosis and by 30% in women who had undergone chemotherapy. The data also showed that in these high-risk subgroups, Femara reduced the risk of cancer spreading to distant parts of the body by 33% and 31%, respectively.

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

According to the release, Femara is now the only medicine in its class approved for use as an initial treatment immediately after surgery in postmenopausal patients with hormone-sensitive early breast cancer, and following completion of five years of tamoxifen therapy (extended adjuvant setting).

The approval of Femara for adjuvant use in the US was based on a six-month priority review. The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the diagnosis, treatment or prevention of disease, increased compliance or demonstrated efficacy in subgroups. Novartis recently received approval for this indication in the UK. Femara has also been submitted in the EU, Japan, and other countries. Additional approvals in other countries are expected in 2006.