Sacituzumab tirumotecan Medicine 04 June 2026 Extended indication Second line or later treatment of locally advanced, recurrent or metastatic unresectable triple negative breast cancer in adults and elderly up to 75 years of age (inclusive) who have progressed on or were intolerable to prior treatment, monotherapy. Therapeutic value Total cost Registration phase Clinical trials Product Active substance Sacituzumab tirumotecan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Second line or later treatment of locally advanced, recurrent or metastatic unresectable triple negative breast cancer in adults and elderly up to 75 years of age (inclusive) who have progressed on or were intolerable to prior treatment, monotherapy. Current proprietary name Already available biosimilars / generics Proprietary name SKB264 Manufacturer MSD Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Powder for injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion (estimated): 31 oktober 2023. De fase III-trial (NCT05347134) wordt alleen in China uitgevoerd en er is geen bewijs dat deze trial wordt uitgevoerd in Europa voor deze indicatie. Er is op dit moment geen aanvullende informatie van de ontwikkelaar, dus er is geen verwachte registratiedatum. Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05347134 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. 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