Novartis AG — Kisqali FDA Summary Review (NDA/BLA 209092, 2024)
Novartis AG · 2024 · FDA Summary Review (Drugs@FDA) · company profile →
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Novartis's Kisqali received regular FDA approval for adjuvant treatment of HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. The NATALEE trial, a global Phase III study of 5101 patients, demonstrated a statistically significant improvement in invasive disease-free survival (iDFS) with ribociclib plus endocrine therapy (ET) versus ET alone (HR 0.749). While overall survival data remains immature, secondary endpoints also showed benefit. The safety profile was consistent with known ribociclib adverse events, with higher incidence of AEs and SAEs in the ribociclib arm, primarily due to increased transaminases and neutropenia, leading to more dose modifications. The FDA noted a favorable benefit/risk, with a 25% relative risk reduction in iDFS, but highlighted underrepresentation of Black patients in the trial.
Key findings — cited to the page
| estimated median duration of grade 3 or higher AST or ALT elevations (recovering to ≤ grade 2) in ribociclib + ET group | 0.7 months | Study O12301C · p.136 |
| incidence of grade ≥3 AEs in non-Asian patients (ribociclib + ET group) | 60.3 % | not Asian · p.144 |
| number of patients with grade ≥ 3 DILI | 5 | Study O12301C · p.135 |
| median time-to-first occurrence of grade ≥ 3 elevated ALT/AST in ET only group | 12.5 months | Study O12301C · p.136 |
| estimated median duration of grade 3 or higher AST or ALT elevations (recovering to ≤ grade 2) in ET only group | 2.2 months | Study O12301C · p.136 |
| incidence of grade ≥3 AEs in Asian patients (ribociclib + ET group) | 76.5 % | Asian · p.144 |
| proportion of patients with grade ≥3 hepatobiliary toxicity grouped AEs in ET only group | 1.7 % | Study O12301C · p.135 |
| median time to first occurrence of Grade 2/3/4 QT prolongation | 2.1 weeks | · p.129 |
| incidence of grade ≥ 3 QT ECG prolonged AESI | 1.0 % | · p.129 |
| median time-to-first occurrence of grade ≥ 3 elevated ALT/AST in ribociclib + ET group | 2.8 months | Study O12301C · p.136 |
| proportion of patients with grade ≥3 hepatobiliary toxicity grouped AEs in ribociclib + ET group | 8.6 % | Study O12301C · p.135 |
| incidence of overdose (grade-3 SAE) | <0.1 % | Study O12301C · p.149 |
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 →