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 (3L).

Proprietary name

Padcev

Manufacturer

Astellas

Mechanism of action

Other

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional comments
Tubulin polymerisation inhibitor.

Registration

Registration route

Centralised (EMA)

Submission date

March 2021

Expected Registration

March 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 derde lijn zijn chemotherapie (docetaxel, paclitaxel or vinflunine), immunotherapie (indien niet gegeven in 2e lijn), klinische studie of Best Supportive Care.

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

50 - 75

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
In 2016 waren er in totaal 3.337 patiënten met blaascarcinoom, hiervan waren 975 patiënten gediagnosticeerd met stadium III/IV. Hiervan zullen er naar verwachting uiteindelijk ongeveer 250-500 een tweedelijns behandeling krijgen. De verwachting is dat er in derde lijn hooguit 50-75 patiënten in aanmerking zullen komen voor deze behandeling.

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 de Verenigde Staten verwacht tussen de $110.000 en $120.000 per patiënt. Dit komt neer op een bedrag van €90.358 tot €98.573

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

Enfortumab Vedotin and Pembrolizumab, With or Without Chemotherapy, versus Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

References
NCT04223856
Additional comments
1e lijns combinatie studie, registratie verwacht medio 2024.

Other information

There is currently no futher information available.