Cetuximab sarotalocan Medicine 03 December 2024 Extended indication Cetuximab sarotalocan monotherapy for third line or later treatment of locoregional, recurrent squamous cell carcinoma of head and neck in adults and elderly who are not eligible for curative treatment. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Cetuximab sarotalocan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Cetuximab sarotalocan monotherapy for third line or later treatment of locoregional, recurrent squamous cell carcinoma of head and neck in adults and elderly who are not eligible for curative treatment. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Rakuten Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Cetuximab, methotrexate, of docetaxel 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 640mg/m² References NCT03769506 (ASP-1929-301) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1). Additional remarks In 2021 werden er 8.943 patiënten met plaveiselcelcarcinoom van de huid van hoofd en hals gediagnosticeerd, waarvan 149 stadium III en IV (1). Gezien dit een derdelijnsbehandeling is zal het verwachte patiëntvolume lager liggen. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks