Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026)
Novartis AG · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
Novartis's Kisqali (ribociclib) received FDA approval on September 16, 2025, for early and advanced/metastatic HR-positive, HER2-negative breast cancer. The drug's efficacy and safety were demonstrated across trials like NATALEE, MONALEESA-2, -3, -7, and COMPLEEMENT-1, showing benefits in progression-free survival, overall survival, and overall response rates. Key safety concerns include QT prolongation, hepatotoxicity, neutropenia, interstitial lung disease/pneumonitis, and severe cutaneous adverse reactions, with detailed incidence rates and dose modification guidelines provided. The report also covers dosage, administration, drug interactions (especially with CYP3A4 inhibitors), use in specific populations, and nonclinical toxicology. A separate FDA review addressed medication error prevention for Kisqali's labeling and packaging.
Key findings — cited to the page
| Grade 3 or 4 increases in AST | 4.7 % | NATALEE · p.73 |
| Grade 4 increases in AST | 0.8 % | NATALEE · p.73 |
| ILD/pneumonitis (Grade 3-4) | 0.3 % | MONALEESA-2, MONALEESA-7 · p.71 |
| Grade 3 or 4 increases in ALT | 8 % | NATALEE · p.73 |
| Grade 4 increases in ALT | 1.5 % | NATALEE · p.73 |
| Incidence of ILD/pneumonitis (Grade 3-4) in advanced or metastatic breast cancer | 0.4% | MONALEESA-2, MONALEESA-3, MONALEESA-7 · p.16 |
| ILD/pneumonitis (Grade 1-2) | 1.5 % | NATALEE · p.71 |
| ILD/pneumonitis (any grade) | 1.2 % | MONALEESA-2, MONALEESA-7 · p.71 |
| Incidence of ILD/pneumonitis (Grade 1-2) in early breast cancer | 1.5% | NATALEE (KISQALI plus NSAI) · p.15 |
| drug-induced liver injury (Grade ≥ 3) | 5 | NATALEE · p.73 |
| Incidence of ILD/pneumonitis (any Grade) in advanced or metastatic breast cancer | 1.6% | MONALEESA-2, MONALEESA-3, MONALEESA-7 · p.16 |
| Grade 3 or 4 increases in ALT | 11 % | MONALEESA-2 and MONALEESA-7 · p.73 |
Source: Novartis AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →