GLSI-100 Medicine 04 June 2026 Extended indication GLSI-100 monotherapy for preventive treatment of HLA-A*02 positive, HER2/neu positive breast cancer in adults and elderly who are at high risk for disease recurrence and completed both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy Therapeutic value Total cost Registration phase Clinical trials Product Active substance GLSI-100 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication GLSI-100 monotherapy for preventive treatment of HLA-A*02 positive, HER2/neu positive breast cancer in adults and elderly who are at high risk for disease recurrence and completed both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Greenwich Portfolio holder Mechanism of action Cancer vaccine Route of administration Intrader meal 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 March 2027 Expected Registration April 2028 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Er zijn nog geen fase 3 resultaten bekend (niet voor december 2026). Resultaten van fase II lieten geen benefit zien op basis van ITT. pmid27589688. Duration of treatment Frequency of administration Dosage per administration References NCT05232916 (FLAMINGO-01) 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 2022 (1). Additional remarks In 2022 waren er 15.691 borstkankerdiagnoses. Tussen de 11 en 13% zijn HER2-positief (n=2.040) (1). 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