Two BRAF-targeted agents already used together in several solid tumors have won parallel regulatory support in Europe. In its March 2026 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending changes to the marketing authorizations for Tafinlar (dabrafenib, Novartis) and Mekinist (trametinib, Novartis).

In melanoma, the CHMP recommended extending the existing indications for both trametinib and dabrafenib to adolescents aged 12 years or older. In differentiated thyroid cancer (DTC), the committee backed a new indication for trametinib in combination with dabrafenib, and for dabrafenib in combination with trametinib, in adults with locally advanced or metastatic BRAF V600E-mutated disease that is refractory to or not eligible for radioactive iodine and has progressed during or after prior systemic therapy. 

Existing adult indications in melanoma and advanced BRAF V600‑mutated non‑small cell lung cancer remain as previously authorized.

Long-Term Benefits in Melanoma 

For melanoma, the regulatory change is an age expansion. CHMP backed broader use of both trametinib and dabrafenib in adolescents aged 12 years or older with unresectable or metastatic melanoma with a BRAF V600 mutation. The same age extension also applies in the adjuvant setting after complete resection of stage III melanoma with a BRAF V600 mutation. 

For trametinib, the existing limitation remains that monotherapy has not demonstrated clinical activity after prior BRAF inhibitor progression.

Precision Strike in Thyroid Cancer 

In DTC, CHMP supported a new adult indication for trametinib and dabrafenib in combination with one another. The new indication applies to adults with locally advanced or metastatic DTC harboring a BRAF V600E mutation whose disease is refractory to radioactive iodine, unsuitable for radioactive iodine, or has progressed during or after prior systemic therapy.

The recommendation for DTC is supported by results from the phase 3 CDRB436J12301 trial, in which dabrafenib plus trametinib showed significant antitumor activity in previously treated, radioactive iodine-refractory, BRAF V600E-mutated DTC. Median progression-free survival was 12.8 months with the combination compared with 3.7 months for placebo, while confirmed objective response rate was 57.4% vs 3.8%.

Clinical Safety and Monitoring 

Confirm BRAF V600E mutation prior to treatment. The approved adult doses are dabrafenib 150 mg twice daily and trametinib 2 mg once daily, both on an empty stomach. 

Common adverse effects with the combination include pyrexia, fatigue, nausea, chills, headache, diarrhea, vomiting, rash, and arthralgia; dose interruptions/reductions may be required for toxicity.

Detailed usage guidelines will be available in the updated Summary of Product Characteristics following final European Commission approval. Marketing authorization changes will take effect following European Commission decisions.