Extended indication

Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously recei

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 comments
Tubulin polymerisation inhibitor.

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.

Therapeutic value

Current treatment options

Huidige behandelopties in de tweede lijn zijn bijvoorbeeld atezolizumab, nivolumab of pembrolizumab.

Therapeutic value

No judgement

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.

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.

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.

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

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

Other information

There is currently no futher information available.