Datopotamab deruxtecan Medicine 04 December 2025 Extended indication Datopotamab deruxtecan with or without osimertinib is indicated for patients with advanced or metastatic EGFRm NSCLC whose disease has progressed on prior Osimertinib. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Datopotamab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Datopotamab deruxtecan with or without osimertinib is indicated for patients with advanced or metastatic EGFRm NSCLC whose disease has progressed on prior Osimertinib. 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 July 2026 Expected Registration July 2027 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 Er zijn nog geen resultaten bekend uit deTROPION-Lung15 studie. Duration of treatment Frequency of administration 3 times every 3 weeks Dosage per administration 6,0mg/kg References TROPION-Lung15 (NCT06417814) 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 Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. Het aantal NSCLC patiënten met EGFR mutaties in 1L is ongeveer 5 tot 10% (375 tot 750). In de praktijk zullen niet alle patiënten vanwege co morbiditeit in aanmerking komen voor een behandeling, maar ongeveer 80% (300 tot 600). Verder is het testgehalte voor mutaties volgens de PALGA database 70%. Dit brengt het totale aantal patiënten op 210 tot 420. De fabrikant geeft aan dat het een patiënten aantal van 458 verwacht en een marktaandeel van 75%. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Nog niet bekend 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