Summary of opinion: Tafinlar, 26/03/2026 Positive

Tafinlar - opinion on variation to marketing authorisation Opinion EMA has issued an opinion on a change to this medicine's authorisation dabrafenib Post-authorisation Human Opinion On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Tafinlar. The marketing authorisation holder for this medicinal product is Novartis Europharm Limited. The CHMP adopted a new indication as follows: Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2). For information, the full indications for Tafinlar will be as follows: Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2). For information, the CHMP also adopted an extension to an existing indication on 26 March 2026 to extend the use of Tafinlar to adolescents from 12 years of age with melanoma. Information on this change is provided in a dedicated summary of opinion available from the EMA website. Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. Notes: New text in bold CHMP post-authorisation summary of positive opinion for Tafinlar (VR0000278305) Adopted Reference Number: EMADOC-1700519818-2971643 English (EN) (158.91 KB - PDF) First published: 27/03/2026 View Key facts Name of medicine Tafinlar EMA product number EMEA/H/C/002604 Active substance dabrafenib mesilate International non-proprietary name (INN) or common name dabrafenib Therapeutic area (MeSH) Melanoma Anatomical therapeutical chemical (ATC) code L01EC02 Marketing authorisation holder Novartis Europharm Limited Date of opinion 26/03/2026 Status Positive News on Tafinlar Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026 27/03/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018 27/07/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017 24/02/2017 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015 24/07/2015 More information on Tafinlar Tafinlar This page was last updated on 27/03/2026 Share this page