Encorafenib Medicine 03 June 2025 Extended indication Encorafenib in combination with binimetinib and pembrolizumab for first line treatment of metastatic or unresectable locally advanced BRAF V600E/K mutation-positive cutaneous melanoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Encorafenib Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Encorafenib in combination with binimetinib and pembrolizumab for first line treatment of metastatic or unresectable locally advanced BRAF V600E/K mutation-positive cutaneous melanoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Braftovi Manufacturer Pierre Fabre Portfolio holder Mechanism of action Serine / threonine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Er wordt op basis van de primary completion datum verwacht dat er mogelijk een indiening gedaan zal worden in augustus 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is eerder een studie gedaan met vemu+cobi+atezo (Imspire150) versus enkel vemu+cobi. Hoewel er destijds positieve resultaten waren heeft het geen plek gekregen omdat er voorkeur werd gegeven aan immunotherapie in de eerstelijn in plaats van BRAF/MEK-remmers. Als monotherapie immunotherapie niet genoeg wordt geacht dan heeft ipi plus nivo combinatie de voorkeur, door de beste kans op lange termijn overleving/curatie (zie DreamSeq trial). Mogelijk zal er dan geen plek in de behandelrichtlijn zijn. Duration of treatment Frequency of administration Dosage per administration References NCT04657991 (STARBOARD) 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 De verwachting is dat het patiëntvolume laag zal uitvallen doordat er waarschijnlijk geen plek is in de behandelrichtlijn. 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