Datopotamab deruxtecan Medicine 05 December 2023 Extended indication Datopotamab deruxtecan as monotherapy is indicated for the 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. 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 Breast cancer Extended indication Datopotamab deruxtecan as monotherapy is indicated for the 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. 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 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Single-agent chemotherapy (eribulin, capecitabine, carboplatin, paclitaxel, Nab-paclitaxel) 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-Breast02 studie. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6,0 mg/kg References TROPION-Breast02 (NCT05374512) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies sluisgeneesmiddel sacituzumab govitecan (Trodelvy®) voor de behandeling van inoperabele of uitgezaaide borstkanker, ZIN 2022 Additional remarks In het pakketadvies wordt een patiëntvolume van 277 ingeschat. Expected cost per patient per year Cost References Additional remarks Not yet known Potential total cost per year Total cost Total cost for sluice Additional remarks Not yet known Off label use Off label use Unknown Indications off label use References Additional remarks There is currently nothing known about off label use. 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 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 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 There is currently no further information available.