FDA approves Novartis' Femara for new breast cancer indication

By E. Janene Geiss

Philadelphia, Dec. 28 - Novartis said Wednesday that the Food and Drug Administration approved Femara (letrozole) in a new indication as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting).

The U.S. approval was based on results of the Breast International Group (BIG 1-98) study, which were published for the first time in the Dec. 29 issue of The New England Journal of Medicine, according to a company news release.

The study 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, officials said.

Femara reduced the risk of breast cancer returning by an additional 21% over the reduction offered by tamoxifen, officials said, and 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, officials said.

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, officials said.

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," Diane Young, vice president and global head of clinical development at Novartis Oncology, said in 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, officials said.

The approval of Femara for adjuvant use in the United States 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 United Kingdom. Femara also has submitted in the European Union, Japan and other countries. Additional approvals in other countries are expected in 2006, officials said.

An affiliate of Novartis AG, Novartis Pharmaceuticals, based in East Hanover, N.J., researches, develops, manufactures and markets leading innovative prescription drugs used to treat diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis.

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