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Datopotamab deruxtecan

Extended indication Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with inoperab
Therapeutic value No estimate possible yet
Registration phase Registration application pending

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 inoperable or metastatic HR-Positive, HER2-negative Breast Cancer who have been treated with one or two prior lines of systemic chemotherapy.
Manufacturer Daiichi Sankyo
Portfolio holder Daiichi Sankyo
Mechanism of action Antibody-drug conjugate
Route of administration Intracavernous
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 March 2024
Expected Registration May 2025
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine)
Therapeutic value No estimate possible yet
Substantiation Er wordt op basis van de studieresultaten niet verwacht dat de PASKWIL-criteria gehaald zullen worden.
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

Expected patient volume per year

Additional remarks Nog niet bekend

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 Er is op dit moment 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 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

Other information

Additional remarks Er is op dit moment nog geen nadere informatie