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Enfortumab vedotin

Medicine

Extended indication Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or progra
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Enfortumab vedotin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Bladder cancer
Extended indication Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting
Proprietary name Padcev
Manufacturer Astellas
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Tubulin polymerisation inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date March 2021
Expected Registration April 2022
Orphan drug No
Registration phase Clinical trials
Additional remarks Verwachte registratiedatum op basis van estimated primary completion date van fase 3 studie in september 2021.

Therapeutic value

Current treatment options Huidige behandelopties in de tweede lijn zijn bijvoorbeeld atezolizumab, nivolumab of pembrolizumab.
Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
Frequency of administration 3 times every 4 weeks
References https://www.bioworld.com/articles/431921-fda-grants-accelerated-approval-for-padcev-to-treat-urothelial-cancer. NCT03474107.
Additional remarks Behandelduur verwacht 4-5 maanden.

Expected patient volume per year

Patient volume < 560

Market share is generally not included unless otherwise stated.
References NKR; Moderate or severe LUTS is associated with increased recurrence of non - muscle - invasive urothelial carcinoma of the bladder. Austin Lunney. Department of Urology, Texas Tech University Health Sciences Center, Lubbock, TX, USA. http://dx.doi.org/10.1590/s1677-5538.ibju.2018.0068
Additional remarks Er zijn 700 patiënten met gemetastaseerde blaaskanker in Nederland. De recurrence rate voor hooggradig urotheel carcinoom bedraagt ongeveer 80%, dit komt neer op een maximaal patiëntvolume van 560. In het geval Enfortumab vedotin in de toekomst ook een indicatie voor de 1e lijn zal ontvangen zal het patiëntvolume hoger uitkomen dan voor enkel de huidige indicatie.

Expected cost per patient per year

References https://www.bioworld.com/articles/431921-fda-grants-accelerated-approval-for-padcev-to-treat-urothelial-cancer
Additional remarks Kosten in Amerika verwacht tussen de $110.000 en$120.000 per patiënt.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer
References NCT03474107A
Additional remarks 1e lijns studie

Other information