Datopotamab deruxtecan Medicine 05 December 2023 Extended indication Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with iDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Datopotamab deruxtecan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with iDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting 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 Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date January 2024 Expected Registration March 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De algehele overleving is met een HR van 0,84 niet significant verschillend. Er werd wel een reductie op het risico van van progressie vrije overleving gevonden in de Dato-DXd arm in vergelijking met de ICC arm (HR 0.63). De verwachting voor nu is dat het waarschijnlijk niet positief zal worden beoordeeld aan de hand van de PASKWIL-criteria. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6,0 mg/kg References TROPION-Breast01 (NCT05104866); https://www.daiichisankyo.com/files/news/pressrelease/pdf/202409/20240923_E.pdf Additional remarks Expected patient volume per year Patient volume < 2,615 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Incidentiecijfers 2022 IKNL; Percentage HR+/HER2 borstkanker Sonabre register; Percentage de Novo metastases en percentage recurrence: IKNL; Percentage 3L chemotherapie: Meegdes M,et al. Int J Cancer. 2022 Jan 1;150(1):124-131. doi: 10.1002/ijc.33785. Epub 2021 Sep 14. PMID: 34460112; PMCID: PMC9290870. Geurts S et al. Chemotherapy use and survival outcomes of patients diagnosed with metastatic HR+/HER2 breast cancer A study of the Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry (NCT 03577197), ESMO BREAST 2023, 219P Additional remarks Incidentie invasieve borstkanker 15.788 patiënten. Waarvan HR+/HER2- (69%)=10.894 patiënten. Hiervan heeft 5% de Novo metastases (545) en 95% heeft stadium I-III (10.349). Van de 10.349 patiënten krijgt 20% recurrence (2.070). Totale incidentie mHR+/HER2- =2.070+545=2.615 patiënten. Patiënten komen in aanmerking voor behandeling met datapotamab deruxtecan als ze behandeld zijn met hormoontherapie en ten minste één lijn chemotherapie. Expected cost per patient per year Cost References 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 op dit moment niets bekend over off label gebruik. Indication extension Indication extensions Yes Indication extensions Treatment of adult patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations (NCT04656652). 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 Manufacturer Additional remarks Other information Additional remarks Er is op dit moment nog geen nadere informatie