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Trastuzumab deruxtecan

Enhertu

Extended indication

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metasta

Therapeutic value

Possible added value
Registration phase

Registered

Product

Active substance

Trastuzumab deruxtecan
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Breast cancer
Extended indication

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
Proprietary name

Enhertu
Manufacturer

AstraZeneca
Mechanism of action

Antibody-drug conjugate
Route of administration

Intravenous
Therapeutical formulation

Injection / infusion solution
Budgetting framework

Intermural (MSZ)
Additional remarks 
HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression Patients in study progressed on, and would no longer benefit from endocrine therapy and have been treated with 1 or 2 prior chemotherapy/ adjuvant in the metastatic setting.

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

June 2022
Expected Registration

January 2023
Orphan drug

No
Registration phase

Registered
Additional remarks 
Fabrikant verwacht indiening in de eerste helft van 2022 en registratie in de eerste helft van 2023. Positieve CHMP opinie in december 2022. Dit geneesmiddel is in de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen.

Therapeutic value

Current treatment options

SoC chemotherapie
Therapeutic value

Possible added value
Substantiation

In het hormoon receptor-positieve cohort, was de mediane progressie-vrije survival 10,1 maanden in de trastuzumab deruxtecan groep en 5,4 maanden in de 'keuze van de arts groep' (hazard ratio for disease progression or death, 0.51; P<0.001), de overall survival was 23,9 maanden en 17,5 maanden, (hazard ratio for death, 0.64; P = 0.003). De verwachting is dat de paskwil-criteria gehaald zullen worden.
Frequency of administration

1 times every 3 weeks
Dosage per administration

5,4mg/kg
References 
DB-04 (NCT03734029). Modi et al. N Engl J Med 2022; 387:9-20.

Expected patient volume per year

Additional remarks 
Het is op dit moment nog niet mogelijk in te schatten hoeveel patiënten van deze nieuwe populatie er in aanmerking zullen komen.

Expected cost per patient per year

Cost

125,143.00
References 
CBS; fabrikant
Additional remarks 
Trastuzumab-deruxtecan is beschikbaar in flacons van 100mg. De apotheekinkoopprijs (AIP) bedraag €1.800 per flacon. De aanbevolen dosering is 5,4mg per kg per behandelcyclus van 21 dagen. Op basis van een gemiddeld gewicht van 72kg bedragen de kosten van trastuzumab-deruxtecan €7.200 per behandelcyclus (4 flacons van €1.800). De kosten per maand zijn dan €10.428,57 ((365/12)*(7.200/21)). De kosten per patiënt per jaar zijn dan €125.143.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension

Yes
Indication extensions

Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2therapies (2L) (NCT03529110). Treatment of HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690). Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710).
References 
Fabrikant

Other information

There is currently no futher information available.