Extended indication

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

Therapeutic value

Possible added value

Total cost


Registration phase

Registration application pending


Active substance

Enfortumab vedotin


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




Mechanism of action

Antibody-drug conjugate

Route of administration


Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional comments
Tubulin polymerisation inhibitor.


Registration route

Centralised (EMA)

Type of trajectory

Accelerated assessment

Submission date

March 2021

Expected Registration

February 2022

Orphan drug


Registration phase

Registration application pending

Additional comments
Fabrikant verwacht registratie in februari 2022.

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

Possible added value


Overall survival was langer in de enfortumab vedotin groep dan in de chemotherapie groep (mediane overall survival, 12.88 versus 8.97 months; hazard ratio for death, 0.70; 95% confidence interval [CI], 0.56 to 0.89; P = 0.001). Progressie-vrije survival was ook langer in de enfortumab vedotin groep dan in the chemotherapie groep (median progression-free survival, 5.55 versus 3.71 months; hazard ratio for progression or death, 0.62; 95% CI, 0.51 to 0.75; P<0.001).

Duration of treatment

Median 5 month / months

Frequency of administration

3 times every 4 weeks

Dosage per administration


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.

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



Fabrikant, EV-301 studie
Additional comments
Mediane behandelduur van 5 maanden en gemiddelde kosten per cyclus (28 dagen) €7.760.

Potential total cost per year

Total cost


This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension


Indication extensions

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

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

Other information

There is currently no futher information available.