OST31-164 Medicine 04 December 2025 Extended indication Ost31-164 monotherapy for maintenance treatment of resected Osteosarcoma recurrent in adolescents and adults up to 39 years of age. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance OST31-164 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Ost31-164 monotherapy for maintenance treatment of resected Osteosarcoma recurrent in adolescents and adults up to 39 years of age. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer OS Therapies Portfolio holder OS Therapies Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: Immunotherapeutisch vaccin Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Yes Submission date June 2026 Expected Registration June 2027 Orphan drug Yes 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 Het gaat om een adjuvante therapie na metastasectomie. In een Open-Label fase 2 Studie werd een werd een overall survival van OST-HER2 91% gevonden, vergeleken met 81%. Duration of treatment Frequency of administration Dosage per administration References NCT04974008 Additional remarks 1x10^9 CFU elke 3 weken gedurende 48 weken Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: prinsesmaximacentrum Additional remarks Osteosarcoom is de meest voorkomende bottumor op de kinderleeftijd. In Nederland krijgen elk jaar ongeveer 15 kinderen een osteosarcoom. De ziekte komt vooral voor in de puberteit en vaker bij jongens dan bij meisjes. Hoewel het zeldzaam is, is osteosarcoom de meest voorkomende vorm van kwaadaardige bottumoren, en komt ook voor bij mensen tussen de 10 en 30 jaar en na 60 jaar (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