Enfortumab vedotin

Active substance
Enfortumab vedotin
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
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

1. Product

Proprietary name
Padcev
Manufacturer
Astellas
Mechanism of action
Other
Route of administration
Intravenous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Tubulin polymerisation inhibitor.

2. Registration

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

3. Therapeutic value

Current treatment options
Huidige behandelopties in de tweede lijn zijn bijvoorbeeld atezolizumab, nivolumab of pembrolizumab.
Therapeutic value
No judgement
Duration of treatment
Not found
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 comments
Behandelduur verwacht 4-5 maanden.

4. 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 comments
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.

5. Expected cost per patient per year

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

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
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 comments
1e lijns studie

9. Other information

There is currently no futher information available.