Trastuzumab deruxtecan

Extended indication	Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Trastuzumab deruxtecan
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Stomach cancer
Extended indication	Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-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	August 2022
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	De fabrikant verwacht registratie in de tweede helft van 2022.

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Op dit moment loopt de DESTINY-Gastric02 studie nog.
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).

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	Op basis van de Amerikaanse verwachte prijs: $13,300 per maand.

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).

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.