The FDA approved Femara (letrozole), a breast cancer drug from Novartis, 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 the treatment of advanced breast cancer in 1997 in women whose cancer had not responded to anti-estrogen drugs.
Femara was shown to be more effective in delaying time to progression of disease than tamoxifen in a double-blind multinational trial of more than 900 postmenopausal women with locally advanced or metastatic breast cancer not amenable to treatment with surgery or radiation. Median time to disease progression with Femara was 9.4 months compared with six months for tamoxifen. Incidence of side effects in the study was similar for both medications, with the most frequently reported side effects including bone pain, hot flushes, back pain, nausea, arthralgia (joint pain) and dyspnea (labored breathing).
"Femara shows great promise for becoming the new first-line therapy of choice for postmenopausal women with advanced breast cancer," said Robert Smith, a doctor with South Carolina Oncology Associates and a lead investigator in the first-line study. "It is the first therapy to challenge tamoxifen in multiple endpoints, including time to progression, response rates and overall clinical benefit."
COPYRIGHT 2001 Lebhar-Friedman, Inc.
COPYRIGHT 2001 Gale Group
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