FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
| T01-03 | Print Media: 301-827-6242 |
| January 10, 2001 | Consumer Inquiries: 888-INFO-FDA |
FDA today approved a new indication for the breast cancer drug, Femara (letrozole) as a first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown, advanced or metastatic breast cancer. Femara, an aromatase inhibitor, was approved for treatment of advanced breast cancer in 1997 in women whose cancer had not responded to antiestrogen drugs.
Femara was shown to be more effective than tamoxifen in a randomized, double-blinded, multinational trial of more than 900 postmenopausal women, with locally advanced or metastatic breast cancer not amenable to treatment with surgery or radiation. In the study, Femara was found superior to tamoxifen in delaying time to progression of disease. Median time to disease progression with Femara was 9.4 months compared to 6 months for tamoxifen.
The incidence of side effects in the study was similar for Femara and tamoxifen with the most frequently reported side effects including bone pain, hot flushes, back pain nausea, arthralgia (or joint pain) and dyspnea (or labored breathing).
On December 13, FDA’s Oncology Drugs Advisory committee unanimously recommended approval of Femara for initial hormone treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown advanced metastatic breast cancer. The drug is manufactured by Novartis Pharmaceuticals Corp., East Hanover, New Jersey.
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