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Trastuzumab deruxtecan

Enhertu

Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Trastuzumab deruxtecan
Domain Oncology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Proprietary name Enhertu
Manufacturer AstraZeneca
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
ATMP No
Submission date October 2021
Expected Registration January 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie november 2022.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation In de DESTINY-Gastric02 werd een respons percentage van 38% gevonden. Het is nog onzeker of fase 2 data voor deze indicatie voldoende zullen zijn voor acceptatie/registratie (zeker in tweede lijn).
Frequency of administration 1 times every 3 weeks
Dosage per administration 6,4mg/kg

Expected patient volume per year

Patient volume

< 78

Market share is generally not included unless otherwise stated.
References IKNL; expertopinie; Record rivoceranib
Additional remarks Ongeveer 70 patiënten worden behandeld in de tweede lijn voor gemetastaseerd adenocarcinoom van de maag of gastro-oesofageale overgang. Het aantal patiënten met een slokdarmcarcinoom die in de tweede lijn worden behandeld bedraagt ongeveer 60. In totaal zijn dit dus 130 patiënten. De inschatting is dat hiervan maximaal 60% een derdelijns behandeling krijgt (78 patiënten).

Expected cost per patient per year

References https://www.fiercepharma.com/special-report/1-enhertu
Additional remarks De verwachte prijs in de Verenigde Staten: $13,300 per maand. De prijs in Nederland is nog niet bepaald.

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-HER2 therapies (2L) (NCT03529110). Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer. Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710).

Other information

There is currently no futher information available.