Enfortumab vedotin

Extended indication	Enfortumab Vedotin and Pembrolizumab in Untreated Locally Advanced or Metastatic Urothelial Cancer
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Enfortumab vedotin
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Bladder cancer
Extended indication	Enfortumab Vedotin and Pembrolizumab in Untreated Locally Advanced or Metastatic Urothelial Cancer
Proprietary name	PADCEV
Manufacturer	Astellas
Portfolio holder	Astellas
Mechanism of action	Antibody-drug conjugate
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
ATMP	No
Submission date	May 2024
Expected Registration	May 2025
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Current treatment options	Platinum-based chemotherapy or checkpoint inhibitor (PDL-1 positive)
Therapeutic value	No estimate possible yet
Substantiation	Op dit moment loopt de studie nog en is het geneesmiddel geregistreerd voor patiënten in de tweede lijn.
Frequency of administration	2 times every 3 weeks
References	NCT04223856

Expected patient volume per year

Patient volume	< 1,108 Market share is generally not included unless otherwise stated.
References	NKR2020 (1);
Additional remarks	In 2020 waren er 705 patiënten met een stadium 3 en 403 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.108 patiënten in aanmerking zullen komen voor enfortumab vedotin in de eerste lijn.

Patient volume

< 1,108

Market share is generally not included unless otherwise stated.

References

NKR2020 (1);

Additional remarks

In 2020 waren er 705 patiënten met een stadium 3 en 403 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.108 patiënten in aanmerking zullen komen voor enfortumab vedotin in de eerste lijn.

Expected cost per patient per year

References	medicijnkosten.nl
Additional remarks	Padcev infusiepoeder flacon 20mg enfortumab vedotine Astellas pharma bv €707,05 per stuk (inclusief BTW) Padcev infusiepoeder flacon 30mg enfortumab vedotine Astellas pharma bv €1.060,57 per stuk (inclusief BTW)

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	MIBC en NMIBC
References	fabrikant

Other information

There is currently no futher information available.