The Food and Drug Administration has approved a new use for the breast cancer drug Femara (letrozole). Femara had been approved to treat women with advanced breast cancer who had not responded to anti-estrogen drugs. The FDA's latest action approves the drug for use as a first-line treatment for postmenopausal women with advanced, metastatic, or hormone receptor positive or hormone receptor unknown breast cancers. Hormone receptor positive tumors are those that may grow when exposed to estrogen.
Femara was shown to be more effective than tamoxifen in a multinational study of more than 900 postmenopausal women whose locally advanced or metastatic breast cancers were not treatable by surgery or radiation.
Among those in the study, Femara significantly slowed the the time to progression of disease when compared to tamoxifen. With Femara, the median time to disease progression was 9.4 months, compared to 6 months with tamoxifen.
The incidence of side effects for Femara and tamoxifen was similar in the study. Side effects reported most frequently included bone pain, hot flushes, back pain, nausea, joint pain, and labored breathing.
Novartis Pharmaceuticals Corp., East Hanover, N.J., manufactures Femara.
COPYRIGHT 2001 U.S. Government Printing Office
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