Treats hormone receptor (HR)-positive, human epidermal growth factor receptor 2…. NDA 209092, held by Novartis. Ribociclib Succinate.
As of Nov 14, 2026, NDA 209092 (Kisqali), held by Novartis, was first approved by FDA on Mar 13, 2017, with 15 approved supplements and 0 published complete response letters.
KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. 1.
| Jul 1, 2026 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Sep 17, 2024 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Jul 22, 2024 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Oct 3, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Dec 10, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 6, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2018 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Mar 13, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| KisqaliEQ 200MG BASE · tablet;oral | Ribociclib Succinate | RxReference drug |
| Jul 1, 2026 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Sep 16, 2025 | Supplement 25Manufacturing | Approved | |
| Jul 28, 2025 | Supplement 24Labeling · Standard review | Approved | |
| Feb 11, 2025 | Supplement 23Labeling · Standard review | Approved | |
| Sep 17, 2024 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Sep 3, 2024 | Supplement 20Manufacturing | Approved | |
| Jul 22, 2024 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2023 | Supplement 16Labeling · Standard review | Approved | |
| Oct 3, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Dec 10, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Jul 6, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Sep 9, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Jul 18, 2018 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Mar 13, 2017 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
