Version 2 (4 June 2024) Version 1 (5 December 2023)

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Datopotamab deruxtecan

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.
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 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	2024
Expected Registration	2025
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Current treatment options	Single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine)
Therapeutic value	No estimate possible yet
Substantiation	Er zijn nog geen resultaten bekend uit de TROPION-Breast01 studie.
Frequency of administration	1 times every 3 weeks
Dosage per administration	6,0 mg/kg
References	TROPION-Breast01 (NCT05104866)

Expected patient volume per year

Additional remarks	Not yet known

Expected cost per patient per year

Additional remarks	Not yet known

Potential total cost per year

Additional remarks	Not yet known

Off label use

Additional remarks	There is currently nothing known about off label use.

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	There is currently no further information available.