Dabrafenib / trametinib Medicine 04 December 2025 Extended indication Extension of indication to include treatment of unresectable or metastatic melanoma with a BRAF V600 mutation and adjuvant treatment of Stage III melanoma with a BRAF V600 mutation for adolescents aged 12 years and older. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Dabrafenib / trametinib Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Extension of indication to include treatment of unresectable or metastatic melanoma with a BRAF V600 mutation and adjuvant treatment of Stage III melanoma with a BRAF V600 mutation for adolescents aged 12 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Tafinlar / Mekinist Manufacturer Novartis Portfolio holder Mechanism of action Combination therapy Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks BRAK en MEK-kinaseremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration May 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van een gemiddelde doorlooptijd van tien maanden. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks