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 comments
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 comments
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 comments
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.