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Datopotamab deruxtecan

Extended indication

Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one

Therapeutic value

Possibly no place in the treatment regimen
Registration phase

Clinical trials

Product

Active substance

Datopotamab deruxtecan
Domain

Oncology
Reason of inclusion

New medicine (specialité)
Main indication

Lung cancer
Extended indication

Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one systemic 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

2024
Expected Registration

2025
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Docetaxel, Platinum doublet
Therapeutic value

Possibly no place in the treatment regimen
Substantiation

Datopotamab deruxtecan (Dato-DXd; DS-1062a) was statistisch significant op progressie-vrije overleving (PFS) vergeleken met standard-of-care docetaxel. Op basis van de resultaten gepresenteerd op de ESMO wordt echter verwacht dat de PASKWIL-criteria niet gehaald zullen worden.
Frequency of administration

1 times every 3 weeks
Dosage per administration

6,0 mg/kg
References 
TROPION-Lung01 (NCT04656652)

Expected patient volume per year

References 
NKR2021; Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker, ZIN 2018; uitgezaaide-kanker-in-beeld-rapport.pdf,
Additional remarks 
In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Uitgaande van stadium III/IV komt dat neer op zo'n 7.478 patiënten. Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium III/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (510 patiënten). In totaal bedraagt deze groep dus zo'n 7.988 patiënten. Van deze groep heeft zo'n 30% een PD-L1 expressie ≥50% (2.396 patiënten) die in aanmerking komen voor immunotherapie. Van deze patiënten zal maximaal 65% een eerstelijnsbehandeling krijgen, dat komt neer op zo'n 1.578 patiënten.

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 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 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.