Datopotamab deruxtecan Medicine 04 December 2025 Extended indication Datopotamab deruxtecan in combination with durvalumab is indicated for the treatment of stage I-III triple-negative breast cancer in patients who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. Therapeutic value No estimate possible yet Total cost € 163,400,000.00 Registration phase Clinical trials Product Active substance Datopotamab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Datopotamab deruxtecan in combination with durvalumab is indicated for the treatment of stage I-III triple-negative breast cancer in patients who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Datroway Manufacturer Daiichi Sankyo Portfolio holder Daiichi Sankyo 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 Normal trajectory Particularity New therapeutical formulation ATMP No Submission date December 2025 Expected Registration December 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De TROPION-Breast03 studie is nog gaande. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References TROPION-Breast03 (NCT05629585) Additional remarks Expected patient volume per year Patient volume 1,900 - 2,850 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2022 Additional remarks Van de patiënten met borstcarcinoom hadden in 2022, 7.001 stadium I, 6.035 stadium II en 1.554 stadium III . Dit komt samen neer op 14.590 patiënten in totaal (1). De totale incidentie TNBC (2022) is naar schatting tussen 2.000 en 3.000 vrouwen. Stadium I t/m III: ongeveer bevat 95 % van de TNB gevallen, dus dat zijn circa 1.900 tot 2.850 patiënten (1). Expected cost per patient per year Cost € < 68,800.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Advies Trodelvy. Zorginstituut Nederland. 2024. Additional remarks De prijs van datopotamab deruxtecan is niet bekend. Mogelijk zijn de kosten gelijk aan het vergelijkbare geneesmiddel sacituzuzumab govitecan (Trodelvy). In het pakketadvies over Trodelvy worden de kosten geschat op €68.707 per patiënt per jaar. Potential total cost per year Total cost € 163,400,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks