Cetuximab Medicine 04 June 2026 Extended indication Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patients who have received prior systemic therapy. Therapeutic value Total cost Registration phase Positive CHMP opinion Product Active substance Cetuximab Domain Oncology Reason of inclusion Indication extension IND Main indication Colon cancer Extended indication Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patients who have received prior systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Erbitux Manufacturer Merck Portfolio holder Merck Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-EGFR monoklonaal antilichaam Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2026 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Therapeutic value 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