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Kisqali Approval History

FDA Approved: Yes (First approved March 13, 2017)
Brand name: Kisqali
Generic name: ribociclib
Dosage form: Tablets
Previous Name: LEE011
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 indicated for the combination treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- metastatic breast cancer.

Development History and FDA Approval Process for Kisqali

DateArticle
Jul 18, 2018Approval Kisqali (ribociclib) Approved for Additional Indications in HR+/HER2- Advanced Breast Cancer
Mar 13, 2017Approval FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer
Dec  9, 2016Novartis LEE011 (ribociclib) plus letrozole analyses show superior PFS across broad spectrum of patients in first-line HR+/HER2- advanced breast cancer versus letrozole
Nov  1, 2016Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer
Oct  8, 2016Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care
Aug  3, 2016Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy Designation as First-Line Treatment for HR+/HER2- Advanced Breast Cancer
May 18, 2016MONALEESA-2 trial of Novartis' LEE011 (ribociclib) stopped due to positive efficacy results at interim analysis in HR+/HER2- advanced breast cancer

Further information

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