Version 2

Nivolumab

Medicine

Extended indication OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic ur
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Nivolumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Bladder cancer
Extended indication OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Proprietary name Opdivo
Manufacturer BMS
Mechanism of action Unknown
Route of administration Unknown
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks NCT03036098

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen

This assessment does not indicate any potential inclusion in the package.
Substantiation De overall survival van de nivolumab-combinatie versus de gemcitabine–cisplatin enkel was (hazard ratio for death, 0,78; 95% confidence interval [CI], 0.63 tot 0,96; P=0.02); de mediane survival was 21,7 maanden (95% CI, 18.6 to 26.4) vergeleken met 18,9 maanden (95% CI, 14.7 to 22.4). Verwachting is dat dit niet voldoet aan PASKWIL-criteria. De nieuwe 1e lijns behandeling wordt mogelijk enfortumab-vedotin.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References NKR2021
Additional remarks In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.213 patiënten in aanmerking zullen komen in de eerste lijn.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information