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Kisqali FDA 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 timeline for Kisqali

DateArticle
Oct 20, 2023Kisqali NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer
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

See also

Kisqali (ribociclib) Consumer information

Further information

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