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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.