FDA backs Novartis' Afinitor for advanced breast cancer

There was good news for Swiss drug major Novartis (NOVN: VX) on Friday, when the US Food and Drug Administration approved the firm’s already marketed Afinitor (everolimus) for an additional indication, for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole). Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease. Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Afinitor in the HR+/HER2-negative population. Additional regulatory submissions are being reviewed by health authorities worldwide

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