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 in the metastatic setting and has progressed on, and would no longer benefit from, endocrine therapy. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Trastuzumab deruxtecan Domain Oncology 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 in the metastatic setting and has progressed on, and would no longer benefit from, endocrine therapy. Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca 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 No Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in de eerste helft van 2022 en registratie in de eerste helft van 2023. Therapeutic value Current treatment options Therapeutic value No estimate possible 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 De verwachte prijs in de Verenigde Staten is: $13,300 per maand. De prijs in Nederland is nog niet bepaald. 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 adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2therapies (2L) (NCT03529110). Treatment of HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690). Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710). References Fabrikant Additional remarks Other information Additional remarks