NOVARTIS — Kisqali FDA Review (NDA/BLA 209092, 2019)
Novartis AG · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA approval and subsequent evaluations of Novartis's KISQALI (ribociclib) for HR-positive, HER2-negative advanced or metastatic breast cancer. Approved indications, dosage, and administration guidelines are detailed. Clinical trials MONALEESA-2, -3, and -7 consistently demonstrated significant improvements in progression-free survival when KISQALI was combined with aromatase inhibitors or fulvestrant. Key safety concerns include neutropenia, hepatobiliary toxicity (ALT/AST elevation), and QT prolongation, which are manageable with dose modifications and monitoring. Pharmacokinetic properties, drug interactions, and effects on special populations are also discussed. The benefit-risk profile is considered favorable, leading to recommendations for expanded indications and ongoing postmarketing commitments for overall survival data.
Key findings — cited to the page
| neutropenia (Grade 4) | 10 % | MONALEESA-2 (KISQALI + letrozole) · p.16 |
| median time to Grade ≥2 neutropenia | 16 days | · p.15 |
| lymphopenia (all grades, placebo + letrozole) | 2 % | MONALEESA-2 (Placebo + letrozole) · p.16 |
| neutropenia (Grade 3) | 50 % | MONALEESA-2 (KISQALI + letrozole) · p.16 |
| median time to resolution to Grade ≤ 2 ALT/AST elevation | 22 days | · p.15 |
| Grade 3/4 decrease in neutrophil count | 58 % | MONALEESA-2, MONALEESA-7 and MONALEESA-3 · p.15 |
| leukopenia (all grades) | 33 % | MONALEESA-2 (KISQALI + letrozole) · p.16 |
| decreased appetite (all grades) | 19 % | MONALEESA-2 (KISQALI + letrozole) · p.16 |
| median time to resolution of Grade ≥3 neutropenia | 12 days | · p.15 |
| neutropenia (all grades) | 75 % | MONALEESA-2 (KISQALI + letrozole) · p.16 |
| median time-to-onset Grade ≥3 ALT/AST elevation | 85 days | · p.15 |
| neutropenia (all grades, placebo + letrozole) | 5 % | MONALEESA-2 (Placebo + letrozole) · p.16 |
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 →