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.