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Enfortumab vedotin

Padcev

Extended indication Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously recei
Therapeutic value Possible added value
Total cost 2,625,000.00
Registration phase Registration application pending

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 Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Tubulin polymerisation inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date March 2021
Expected Registration February 2022
Orphan drug Yes
Registration phase Registration application pending
Additional remarks 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
Substantiation 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 1,25mg/kg
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

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 remarks 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

Cost 42,000.00
References Fabrikant, EV-301 studie
Additional remarks Mediane behandelduur van 5 maanden en gemiddelde kosten per cyclus (28 dagen) €7.760.

Potential total cost per year

Total cost

2,625,000.00

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 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 remarks 1e lijns combinatie studie, registratie verwacht medio 2024.

Other information

There is currently no futher information available.