Novartis drug Femara wins approval in Germany; new clinical trial planned

By Elaine Rigoli

Tampa, Fla., March 20 - Novartis announced Monday that Femara (letrozole) has received approval in Germany for use after surgery in postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting).

This is the first major European market approval for this additional indication under the European mutual recognition procedure, according to a news release.

The approval was based on results from the BIG 1-98 study, a comparison of Femara versus tamoxifen, which demonstrated that Femara reduced the risk of breast cancer recurrence by an additional 19%. The benefit of Femara was most evident in women with a higher risk of recurrent breast cancer, the release said.

To better define the optimal adjuvant treatment for these patients at higher risk, Novartis said it has begun the FACE (Femara vs. Anastrozole clinical evaluation) trial. This is the first comparative study of these two aromatase inhibitors in the post-surgery setting and is expected to enroll 4,000 women worldwide.

Femara is used in patients with hormone-related breast cancer as either initial treatment immediately after surgery or after they have completed five years of tamoxifen therapy (extended adjuvant setting).

Basel, Switzerland-based Novartis develops both patented and generic pharmaceuticals.

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