dabrafenib + trametinib
Oncology· 402 cited findings· 1 source document
Company: Novartis AG →
What the regulatory reviews say
Dabrafenib + trametinib is a combination therapy. In a clinical trial, the median progression-free survival (PFS) for dabrafenib + trametinib (D+T) was 15.5 months (local investigator assessment), compared to 5.5 months for the placebo arm. The PFS Hazard Ratio for D+T versus placebo was 0.34 (BIRC assessment with covariates) and 0.37 (treatment policy strategy). The overall survival (OS) Hazard Ratio was 0.66.
Regarding safety, 42.6% of patients in the D+T arm discontinued blinded treatment, with 18.8% discontinuing due to progressive disease. In the placebo arm, 75.0% of patients discontinued blinded treatment, with 59.6% discontinuing due to progressive disease. Discontinuation due to adverse events occurred in 3.0% of patients in the D+T arm.
The application for this Type II variation was submitted on 25 August 2025, and the CHMP opinion date was 26 March 2026. The dabrafenib dose used in the trial was 150 mg BID, and the trametinib dose was 2 mg QD.
Key figures — cited to the source page
| Median PFS (local investigator assessment, D+T arm) | 15.5 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.38 |
| Median PFS (local investigator assessment, placebo arm) | 5.5 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.38 |
| PFS Hazard Ratio (BIRC assessment with covariates, D+T vs Placebo) | 0.34 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.38 |
| OS HR | 0.66 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.77 |
| Percentage of D+T arm discontinued blinded treatment | 42.6 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.27 |
| Percentage of placebo arm discontinued blinded treatment | 75.0 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.27 |
| Percentage of D+T arm discontinued due to AE | 3.0 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.27 |
| CHMP opinion date | 26 March 2026 | Novartis AG — Mekinist EMA EPAR variation assessment report, p.7 |
Source documents
Explore the full evidence
All 402 cited findings for dabrafenib + trametinib — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.