Nivolumab

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.
Therapeutic value	Possibly no place in the treatment regimen
Registration phase	Clinical trials

Product

Active substance	Nivolumab
Domain	Oncology
Reason of inclusion	Indication extension
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
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
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
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.

Possibly no place in the treatment regimen

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

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

There is currently nothing known about the expected cost.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.