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FDA approves Novartis drug as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor

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FDA has approved ribociclib (Kisqali—Novartis) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

FDA has approved ribociclib (Kisqali—Novartis) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The drug, a CDK4/6 inhibitor, was approved based on a first-line Phase III trial that met its primary endpoint early, showing statistically significant improvement in progression-free survival compared with letrozole alone at the first pre-planned interim analysis. The drug was approved under the FDA Breakthrough Therapy designation and Priority Review programs.

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https://globenewswire.com/news-release/2017/03/13/936000/0/en/Novartis-Kisqali-ribociclib-LEE011-receives-FDA-approval-as-first-line-treatment-for-HR-HER2-metastatic-breast-cancer-in-combination-with-any-aromatase-inhibitor.html

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