Expand all sections

Datopotamab deruxtecan

Extended indication Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with locally
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Datopotamab deruxtecan
Domain Oncology
Reason of inclusion Indication extension
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.
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)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
ATMP No
Submission date July 2025
Expected Registration July 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks inschatting fabrikant

Therapeutic value

Current treatment options Single-agent chemotherapy (eribulin, capecitabine, carboplatin, paclitaxel, Nab-paclitaxel)
Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen resultaten bekend uit deTROPION-Breast02 studie.
Frequency of administration 1 times every 3 weeks
Dosage per administration 6,0 mg/kg
References TROPION-Breast02 (NCT05374512)

Expected patient volume per year

References Pakketadvies sluisgeneesmiddel sacituzumab govitecan (Trodelvy®) voor de behandeling van inoperabele of uitgezaaide borstkanker, Zorginstituut 2022
Additional remarks In het pakketadvies wordt een patiëntvolume van 277 ingeschat.

Expected cost per patient per year

Additional remarks Nog niet bekend

Potential total cost per year

Additional remarks Nog niet bekend

Off label use

Additional remarks Op dit moment is er niets bekend over off label gebruik.

Indication extension

Indication extension 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 Fabrikant

Other information

Additional remarks Er is nog geen verdere informatie beschikbaar.