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Enfortumab vedotin

PADCEV

Extended indication

Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unre

Therapeutic value

Possible added value
Registration phase

Registered

Product

Active substance

Enfortumab vedotin
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Bladder cancer
Extended indication

Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy.
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

September 2024
Orphan drug

No
Registration phase

Registered
Additional remarks 
Positieve CHMP opinie juli 2024 en EC decision in augustus 2024.  Deze indicatieuitbreiding voldoet aan het sluiscriterium van >€20.000.000 per jaar.

Therapeutic value

Current treatment options

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

Possible added value
Substantiation

Het geneesmiddel is geregistreerd voor patiënten in de tweede lijn. OS: (median, 31.5 months versus 16.1 months; hazard ratio for death, 0.47; 95% CI, 0.38 to 0.58; P<0.001). Voldoet daarmee aan PASKWIL-criteria.
Frequency of administration

2 times every 3 weeks
References 
NCT04223856 (EV-302); Powles et al. N Engl J Med. 2024.

Expected patient volume per year

Patient volume

< 713

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. In totaal 1.213 patiënten. In dat jaar zijn 713 patiënten behandeld met  chemotherapie. (1)

Expected cost per patient per year

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

Padcev infusiepoeder flacon 30mg enfortumab vedotine Astellas Pharma €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
References 
fabrikant

Other information

There is currently no futher information available.