The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending amendments to the marketing authorisation terms for Dabrafenib and Trametinib.
Information on Newly Added Indications
The CHMP of the EMA has approved the following expansions to existing indications:
1. Expanded Indication for Melanoma
Dabrafenib as monotherapy or in combination with Trametinib, and Trametinib as monotherapy or in combination with Dabrafenib, are indicated for the treatment of unresectable or metastatic melanoma harbouring the BRAF V600 mutation in adults and adolescents aged 12 years and older.
Note: Trametinib monotherapy has not demonstrated clinical activity in patients with disease progression following prior BRAF inhibitor therapy.
2. Expanded Indication for Adjuvant Treatment of Melanoma
Dabrafenib in combination with Trametinib, and Trametinib in combination with Dabrafenib, are indicated for adjuvant treatment of stage III melanoma harbouring the BRAF V600 mutation in adults and adolescents aged 12 years and older following complete surgical resection.
3. New Indication for Differentiated Thyroid Cancer
Dabrafenib in combination with Trametinib, and Trametinib in combination with Dabrafenib, are indicated for the treatment of locally advanced or metastatic differentiated thyroid cancer harbouring the BRAF V600E mutation in adult patients who are refractory to or ineligible for radioactive iodine therapy and have experienced disease progression during or after prior systemic therapy.
The EMA’s latest approval for expanded indications of Trametinib and Dabrafenib marks further advancement in the application of combined BRAF/MEK targeted therapy across multiple tumour types. From first line treatment for unresectable or metastatic melanoma, to postoperative adjuvant therapy for reducing recurrence risk, and further to radioactive iodine refractory differentiated thyroid cancer—a field long lacking effective therapeutic options—the Trametinib Dabrafenib combination delivers a more comprehensive and consistent treatment option for patients with BRAF V600 mutations.
With continuous expansion of its indications, this dual target combination regimen is expected to benefit a broader patient population. It also further validates the great potential of molecular stratified personalised treatment strategies in improving patient outcomes in the era of precision medicine.
