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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.