Galinpepimut-S Medicine 04 December 2025 Extended indication Galinpepimut-S monotherapy for third line, maintenance treatment of acute myeloid leukaemia in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Galinpepimut-S Domain Hematology Reason of inclusion New medicine (specialité) Main indication AML / MDS Extended indication Galinpepimut-S monotherapy for third line, maintenance treatment of acute myeloid leukaemia in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer SELLAS Portfolio holder SELLAS Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date May 2026 Expected Registration April 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment dienen resultaten nog afgewacht te worden. Duration of treatment Frequency of administration Dosage per administration References NCT04229979 (REGAL) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2023 Additional remarks In Nederland krijgen jaarlijks gemiddeld zo’n 800 mensen de diagnose acute myeloïde leukemie (AML). 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