Enfortumab vedotin

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.
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)

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.