Extended indication

Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with inoperab

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.