Pembrolizumab Medicine 03 June 2025 Extended indication Pembrolizumab in combination with standard of care radiotherapy for neoadjuvant, adjuvant treatment of newly diagnosed stage III/IVA, resectable, locoregionally advanced Squamous cell carcinoma of head and neck in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication Pembrolizumab in combination with standard of care radiotherapy for neoadjuvant, adjuvant treatment of newly diagnosed stage III/IVA, resectable, locoregionally advanced Squamous cell carcinoma of head and neck in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor 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 June 2025 Expected Registration January 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fabrikant heeft gemeld dat de KEYNOTE-689 trial het primaire eindpunt van event-free survival (EFS) heeft behaald (2). Er zijn nog geen andere resultaten bekend. Duration of treatment Frequency of administration Dosage per administration 200mg References NCT03765918 (KEYNOTE-689) (1); MSD persbericht. 2024 (2). Additional remarks Expected patient volume per year Patient volume < 1,474 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 Additional remarks Er waren in 2022 1.474 patiënten met hoofd- en halskanker die chirurgie zijn ondergaan. Expected cost per patient per year Cost References Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement. 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