Novartis AG — Kisqali EMA EPAR public assessment report (EMEA/H/C/004213, 2017)
Novartis AG · 2017 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. The CHMP issued a positive opinion on June 22, 2017, based on a favorable benefit-risk assessment. Non-clinical studies detailed ribociclib's CDK4/6 inhibition, anti-tumor activity, and reversible toxicity in animal models. Pharmacokinetic analysis characterized its absorption, distribution, metabolism (primarily via CYP3A4), and elimination, noting impacts of organ impairment and drug interactions. Clinical trials, particularly the MONALEESA-2 study, demonstrated significant improvement in progression-free survival (median 25.3 vs. 16.0 months) and higher overall response rates for ribociclib plus letrozole compared to placebo. Key safety concerns, including myelosuppression, hepatobiliary toxicity, and QTc prolongation, were identified but deemed manageable with risk minimization strategies. The overall safety profile was considered acceptable.
Key findings — cited to the page
| Grade 3 nausea/emesis events | 5 % | · p.93 |
| Grade 3/4 thrombocytopenia AEs | 2 | · p.93 |
| median time to resolution of grade ≥ 3 neutropenia | 15 days | · p.93 |
| median time to resolution of grade ≥ 2 neutropenia | 32 days | · p.93 |
| Grade 3/4 leukopenia AEs (experimental arm) | 10 % | · p.93 |
| Grade 3/4 leukopenia AEs (control arm) | 0.6 % | · p.93 |
| Grade 4 neutropenic events | 10 % | · p.92 |
| Grade 3 neutropenic events | 50 % | · p.92 |
| Grade 3 or 4 decrease in neutrophil counts | 59.6 % | · p.92 |
| median time-to-onset of grade ≥ 2 neutropenia | 16 days | · p.93 |
| Grade 3/4 anaemia events (both arms) | 1.2 % | · p.93 |
| Grade 3/4 infectious events (experimental arm) | 4 % | · p.93 |
Source: Novartis AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →