Trastuzumab deruxtecan Medicine 08 December 2020 Extended indication Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy Therapeutic value No judgement yet Total cost Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy 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 HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression Patients in study progressed on, and would no longer benefit from endocrine therapy and have been treated with 1 or 2 prior chemotherapy/ adjuvant in the metastatic setting Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2021 Expected Registration 2022 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in H2 2021 en registratie in 2022. Therapeutic value Current treatment options Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation De DESTINY-Breast04 studie loopt op dit moment nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 5,4mg/kg References DB-04 (NCT03734029) 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 Het is op dit moment nog niet mogelijk in te schatten hoeveel patiënten van deze nieuwe populatie er in aanmerking zullen komen. 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 Yes Indication extensions Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690) References Fabrikant Additional remarks Other information Additional remarks