Datopotamab deruxtecan Medicine 05 December 2023 Extended indication Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one systemic therapy. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase No registration expected Product Active substance Datopotamab deruxtecan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name 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 March 2024 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De indicatie is vrijwillig ingetrokken door de fabrikant. Therapeutic value Current treatment options Docetaxel, Platinum doublet Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Datopotamab deruxtecan (Dato-DXd; DS-1062a) was statistisch significant op progressie-vrije overleving (PFS) vergeleken met standard-of-care docetaxel. Op basis van de resultaten gepresenteerd op de ESMO wordt echter verwacht dat de PASKWIL-criteria niet gehaald zullen worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6,0 mg/kg References TROPION-Lung01 (NCT04656652) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021; Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker, ZIN 2018; uitgezaaide-kanker-in-beeld-rapport.pdf, Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Uitgaande van stadium III/IV komt dat neer op zo'n 7.478 patiënten. Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium III/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (510 patiënten). In totaal bedraagt deze groep dus zo'n 7.988 patiënten. Van deze groep heeft zo'n 30% een PD-L1 expressie ≥50% (2.396 patiënten) die in aanmerking komen voor immunotherapie. Van deze patiënten zal maximaal 65% een eerstelijnsbehandeling krijgen, dat komt neer op zo'n 1.578 patiënten. Expected cost per patient per year Cost References Ahn MJ et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2024 Sep 9:JCO2401544. doi: 10.1200/JCO-24-01544. Additional remarks Nog niet bekend Potential total cost per year Total cost Total cost for sluice Additional remarks Nog niet bekend Off label use Off label use Unknown Indications off label use References Additional remarks Er is momenteel niets bekend over off-labelgebruik. Indication extension Indication extensions Yes Indication extensions Treatment of adult patients with inoperable or metastatic HR-Positive, HER2-negative Breast Cancer who have been treated with one or two prior lines of systemic chemotherapy (NCT05104866). Treatment of adult patients with locally recurrent inoperable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (NCT05374512). Treatment of adult patients with advanced or metastatic NSCLC without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression and who have not previously received systemic therapy for advanced or metastatic NSCLC (NCT05215340). References Fabrikant Additional remarks Other information Additional remarks Momenteel is er geen verdere informatie beschikbaar.