Novartis AG — Spexotras EMA EPAR public assessment report (EMEA/H/C/005886, 2024)
Novartis AG · 2024 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted a positive opinion for Spexotras (trametinib) in combination with dabrafenib for pediatric BRAF V600E-mutated low-grade glioma (LGG) and high-grade glioma (HGG). This report details the regulatory process, chemical, pharmaceutical, and non-clinical aspects, including safety assessments. Pediatric formulations and pharmacokinetic data were evaluated. The pivotal Phase II study G2201 demonstrated superior objective response rates and progression-free survival for dabrafenib/trametinib in LGG compared to chemotherapy, and clinically relevant efficacy in HGG. The safety profile was manageable and consistent with known BRAF/MEK inhibitor treatments, with pyrexia being common. Long-term safety, especially for skeletal and sexual maturation, requires ongoing monitoring.
Key findings — cited to the page
| patients with grade 5 AEs (LGG cohort) | 0 | G2201 · p.101 |
| patients with grade 3 AEs (HGG cohort) | 65.9 % | G2201 · p.101 |
| incidence of grade ≥3 AEs suspected to be study treatment related (C+V arm, LGG cohort) | 87.9 % | G2201 · p.101 |
| patients with grade 4 AEs (LGG cohort) | 4.1 % | G2201 · p.101 |
| patients with grade 5 AEs (HGG cohort) | 7.3 % | G2201 · p.102 |
| patients with grade 4 AEs (HGG cohort) | 19.5 % | G2201 · p.102 |
| patients with Grade ≥3 AEs (combination therapy pool) | 57.3 % | · p.98 |
| incidence of grade ≥3 AEs suspected to be study treatment related (D+T arm, LGG cohort) | 26.0 % | G2201 · p.101 |
| patients with grade ≥3 AEs (D+T arm, LGG cohort) | 46.6 % | G2201 · p.101 |
| patients with grade ≥3 AEs (C+V arm, LGG cohort) | 93.9 % | G2201 · p.101 |
| Grade >3 Rash in C+V arm | 3.0% | G2201 (LGG cohort) · p.134 |
| Grade 3/4 lymphocytes decreased | 1.4 % | · p.109 |
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 →