New Use for Breast Cancer Drug OK'd
FDA Clears Femara for Postmenopausal Women After Breast Cancer Surgery
Dec. 29, 2005 -- The FDA has approved a new use for the breast cancer drug
Femara may now be taken by postmenopausal women with early,
hormone-sensitive breast cancer immediately after surgery.
Femara had previously been an option for postmenopausal women with
hormone-sensitive breast cancer who had already taken another breast cancer
Novartis -- the maker of Femara -- says Femara has already been approved for
the same use in the U.K. and expects additional approvals in other countries in
According to an FDA announcement, Femara's effectiveness in treating early
breast cancer is based on an analysis of disease-free survival in patients who
were treated and followed for an average of two years.
"Follow-up analyses will determine long-term outcomes for both safety
and efficacy," states the FDA.
A news release from Novartis adds more details. Novartis states that the
approval was based on results of a large,
international study published in The New England Journal of
In that study, postmenopausal women with hormone-sensitive early breast
cancer were less likely to get breast cancer again if they took Femara instead
of another breast cancer drug, tamoxifen, which also helped prevent breast
Femara and tamoxifen both target the female sex hormone, estrogen, which
fuels some (but not all) breast cancers. But the two drugs work
Tamoxifen, an older drug, has long been a cornerstone of breast cancer
treatment. It blocks estrogen from binding onto cells.
Femara belongs to a newer (and more costly) family of drugs called aromatase
inhibitors. Aromatase inhibitors target estrogen production, curbing the
Aromatase inhibitors can raise a woman's risk of developing osteoporosis
(thinning bones). In the Femara-tamoxifen study published in The New
England Journal of Medicine, women taking Femara were more likely to
fracture a bone than those taking tamoxifen.