Novartis AG — Tafinlar EMA EPAR variation assessment report (EMEA/H/C/002604, 2013)
Novartis AG · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
Novartis Europharm Limited submitted a Type II variation application for Tafinlar (dabrafenib) and Mekinist (trametinib) to expand their indication to BRAF V600E mutation-positive differentiated thyroid cancer (DTC). This application is supported by the primary analysis of the pivotal Phase 3 study CDRB436J12301, which assessed the efficacy and safety of the combination therapy in patients with locally advanced or metastatic, radioactive iodine refractory DTC. The study design involved a 2:1 randomization of dabrafenib plus trametinib versus placebo, with progression-free survival as the primary endpoint and objective response rate and overall survival as key secondary endpoints. Pharmacokinetic data from the study confirmed consistent drug exposure across ethnicities.
Key findings — cited to the page
| Percentage of patients still receiving blinded D+T treatment | 57.4 % | · p.27 |
| Application submission date | 25 August 2025 | · p.6 |
| CHMP opinion date | 26 March 2026 | · p.7 |
| Trial phase | Phase III | CDRB436J12301 · p.14 |
| Planned enrollment | 150 patients | CDRB436J12301 · p.14 |
| Actual enrollment | 153 patients | CDRB436J12301 · p.14 |
| Dabrafenib + Trametinib arm enrollment | 101 patients | CDRB436J12301 · p.14 |
| Placebo arm enrollment | 52 patients | CDRB436J12301 · p.14 |
| First patient first visit (FPFV) | 15-Nov-2021 | CDRB436J12301 · p.14 |
| Last patient last visit (LPFV) | 09-May-2024 | CDRB436J12301 · p.14 |
| Data cut-off (DCO) for primary analysis | 22-Jan-2025 | CDRB436J12301 · p.14 |
| Patients still receiving blinded D+T treatment | 58 | · p.27 |
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 →