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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 Registration application pending

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 March 2024
Expected Registration May 2025
Orphan drug No
Registration phase Registration application pending

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

References Ahn MJ et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2024 Sep 9:JCO2401544. doi: 10.1200/JCO-24-01544.
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.