Novartis AG — Kisqali EMA EPAR variation assessment report (EMEA/H/C/004213, 2017)
Novartis AG · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Kisqali (ribociclib) based on a prematurely terminated pediatric study (CLEE011Q12101). The study investigated ribociclib in combination with topotecan and temozolomide (TOTEM) for relapsed or refractory neuroblastoma and other solid tumors. It was halted due to intolerable dose-limiting toxicities and high-grade hematological adverse events, preventing the determination of a safe recommended Phase II dose. No objective responses were observed, and the combination was deemed unsuitable for further investigation in pediatric patients.
Key findings — cited to the page
| Grade 4 dyspnoea and death | 1 subject | CLEE011Q12101 · p.5 |
| participants with grade 5 SAE | 1 participant | Q12101 · p.23 |
| participants with grade 3 AEs | 2 participants | Q12101 · p.21 |
| participants with grade 5 AEs (percentage) | 8.3 % | Q12101 · p.21 |
| participants with grade 3 AEs (percentage) | 16.7 % | Q12101 · p.21 |
| participants with grade 5 AEs | 1 participant | Q12101 · p.21 |
| participants with grade 4 AEs (percentage) | 66.7 % | Q12101 · p.21 |
| participants with grade 4 AEs | 8 participants | Q12101 · p.21 |
| Procedure No. | EMA/VR/0000315309 | · p.1 |
| Invented name | Kisqali | · p.1 |
| Ribociclib monotherapy recommended dose for expansion in paediatric patients | 350 mg/m2/day | CLEE011X2102 · p.9 |
| Ribociclib monotherapy MTD in paediatric patients | 470 mg/m2/day | CLEE011X2102 · p.9 |
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 →