Trastuzumab deruxtecan Medicine 08 December 2020 Extended indication Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Trastuzumab deruxtecan Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer Daiichi Sankyo Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2020 Expected Registration 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie in 2022. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt de DESTINY-Gastric02 studie nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6,4mg/kg References Additional remarks Expected patient volume per year Patient volume < 78 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL; expertopinie; Record rivoceranib Additional remarks Ongeveer 70 patiënten worden behandeld in de tweede lijn voor gemetastaseerd adenocarcinoom van de maag of gastro-oesofageale overgang. Het aantal patiënten met een slokdarmcarcinoom die in de tweede lijn worden behandeld bedraagt ongeveer 60. In totaal zijn dit dus 130 patiënten. De inschatting is dat hiervan maximaal 60% een derdelijns behandeling krijgt (78 patiënten). Expected cost per patient per year Cost References https://www.fiercepharma.com/special-report/1-enhertu Additional remarks Op basis van de Amerikaanse verwachte prijs: $13,300 per maand. 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