Tafinlar (dabrafenib) + trametinib
Oncology· 45 cited findings· 1 source document
Company: Novartis AG →
What the regulatory reviews say
Tafinlar (dabrafenib) + trametinib is a combination therapy evaluated in a Phase III clinical trial with an actual enrollment of 153 patients. The trial commenced with the first patient's first visit on 15-Nov-2021. The study included 101 patients in the Dabrafenib + Trametinib arm and 52 patients in the placebo arm.
Efficacy results showed that 57.4% of patients (58 patients) were still receiving blinded D+T treatment, with a median duration of exposure of 63.14 weeks (14.7 months). In contrast, 25.0% of patients (13 patients) were still receiving blinded placebo treatment, with a median duration of exposure of 23.93 weeks (5.6 months). Discontinuation rates for blinded D+T treatment were 42.6% (43 patients), while for blinded placebo treatment, it was 75.0% (39 patients). Discontinuation due to progressive disease was 18.8% for D+T treatment and 59.6% for placebo treatment.
Regarding safety, 3.3% of patients (5 patients) discontinued blinded study treatment due to adverse events (AE). Specifically, 3.0% of patients (3 patients) in the D+T arm discontinued due to AE, and 3.8% of patients (2 patients) in the placebo arm discontinued due to AE. The application for this treatment was submitted on 25 August 2025, and a CHMP opinion was issued on 26 March 2026.
Key figures — cited to the source page
| Percentage of patients still receiving blinded D+T treatment | 57.4 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| Percentage of patients still receiving blinded placebo treatment | 25.0 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| Median duration of exposure to D+T | 14.7 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| Median duration of exposure to placebo | 5.6 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| D+T treatment discontinuation due to progressive disease | 18.8 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| Placebo treatment discontinuation due to progressive disease | 59.6 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| Percentage of D+T treatment discontinuation due to AE | 3.0 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.27 |
| CHMP opinion date | 26 March 2026 | Novartis AG — Tafinlar EMA EPAR variation assessment report, p.7 |
Source documents
Explore the full evidence
All 45 cited findings for Tafinlar (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.