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Novartis says Femara shows benefit after prolonged period of no treatment
By Elaine Rigoli
Tampa, Fla., March 23 - Women with hormone-sensitive early breast cancer who switched to Femara (letrozole, an aromatase inhibitor) from a placebo as part of a trial experienced significant improvements in overall survival, disease-free survival and risk of distant metastases, according to a Novartis news release issued Thursday.
The MA-17 trial was designed to determine whether longer-term treatment with an aromatase inhibitor post-tamoxifen therapy would offer any clinical benefit to postmenopausal women with early breast cancer, the release said.
As such, the women taking part in the study had already completed a standard five-year course of tamoxifen, and were then given either Femara or a placebo, the release said.
In 2003, results of an interim analysis showed that Femara reduced the risk of breast cancer coming back by 42% compared with a placebo. These data prompted an independent Data Safety Monitoring Board to recommend the unblinding of study results.
Since then, 1,655 women taking a placebo have chosen to switch to Femara, while another 613 women did not pursue further treatment, the release said.
In this new analysis, postmenopausal women who switched from a placebo to Femara experienced a 69% reduction in the risk of recurrence. There also was a 72% reduction in the risk that the cancer would spread to a distant part of the body, the release said.
A 47% reduction in the risk of dying from their disease was also observed.
These data are not currently included in the approved licensed indication for Femara, the release said.
Based in Basel, Switzerland, Novartis develops both patented and generic pharmaceuticals.
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