FDA approves Afinitor for advanced breast cancer

Drug already approved for kidney, pancreatic cancers

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a Novartis cancer drug.

The drug maker said Friday that the FDA had approved Afinitor (everolimus) combined with exemestane for postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer who have failed treatment with letrozole or anastrozole.

"Afinitor is the first and only treatment that boosts the effectiveness of endocrine therapy, significantly extending the time women with advanced breast cancer live without tumor progression," University of Texas M.D. Anderson Cancer Center chair of breast medical oncology Gabriel Hortobagyi said. "This approval redefines the treatment and management of advanced hormone receptor-positive breast cancer, offering a critical new option for physicians and patients."


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