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Nivolumab

Opdivo

Extended indication

OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of

Therapeutic value

No estimate possible yet
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

August 2024
Expected Registration

September 2025
Orphan drug

Yes
Registration phase

Clinical trials
Additional remarks 
NCT03036098

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

De resultaten van CHECKMATE 901 moeten worden afgewacht.

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.