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Enfortumab vedotin

PADCEV

Extended indication

Enfortumab vedotin and pembrolizumab in untreated locally advanced or metastatic urothelial cancer.
Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

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

January 2024
Expected Registration

October 2024
Orphan drug

No
Registration phase

Registration application pending

Therapeutic value

Current treatment options

Platinum-based chemotherapy or checkpoint inhibitor (PDL-1 positive)
Therapeutic value

No estimate possible yet
Substantiation

het geneesmiddel is geregistreerd voor patiënten in de tweede lijn. Tijdens ESMO 2023 is er een sterk positieve studie gepresenteerd. 33% van de patiënten was nog on treatment ten tijde van analyse, maar geen (mediane) duur van behandeling te destilleren. Het gaat tot verschuiving van eerstelijns behandeling leiden.
Frequency of administration

2 times every 3 weeks
References 
NCT04223856

Expected patient volume per year

Patient volume

< 1,213

Market share is generally not included unless otherwise stated.
References 
NKR2021 (1);
Additional remarks 
In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.213 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.