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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.