Novartis AG — Finlee EMA EPAR public assessment report (EMEA/H/C/005885, 2023)
Novartis AG · 2023 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report assesses Finlee (dabrafenib) with trametinib for pediatric BRAF V600E mutation-positive low-grade glioma (LGG) and high-grade glioma (HGG). Finlee, an orphan medicinal product, is a dispersible tablet. Non-clinical and clinical studies, including extensive pharmacokinetic analyses, supported its development. The pivotal G2201 study demonstrated significant efficacy: in LGG, dabrafenib plus trametinib (D+T) showed superior objective response rate (ORR) and progression-free survival (PFS) compared to chemotherapy; in HGG, D+T achieved a clinically relevant ORR. The safety profile, generally manageable and consistent with adults, identified pyrexia, headache, and weight gain as common adverse events.
Key findings — cited to the page
| incidence of weight increased (grade 3, LGG cohort D+T arm) | 6.8 % | · p.114 |
| incidence of investigations (grade 3, LGG cohort D+T arm) | 21.9 % | · p.114 |
| patients with grade 3 AEs (LGG cohort D+T arm) | 46.6 % | · p.114 |
| patients with grade ≥3 treatment-related AEs (HGG cohort) | 26.8 % | · p.114 |
| incidence of pyrexia (grade 3, LGG cohort D+T arm) | 8.2 % | · p.114 |
| incidence of infections and infestations (grade 3, LGG cohort D+T arm) | 11 % | · p.114 |
| photo irritation factor (PIF) for dabrafenib | >83 | · p.24 |
| Grade ≥3 AEs | 57.3% | combination therapy pool · p.111 |
| incidence of grade ≥3 treatment-related AEs (D+T arm) | 26.0 % | · p.114 |
| incidence of grade ≥3 treatment-related AEs (C+V arm) | 87.9 % | · p.114 |
| incidence of neutropenia (grade 3, LGG cohort D+T arm) | 9.6 % | · p.114 |
| incidence of ALT increased (grade 3, LGG cohort D+T arm) | 5.5 % | · p.114 |
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 →