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Nivolumab

Opdivo

Extended indication Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as fir
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) based on study CA2099DW
Proprietary name Opdivo
Manufacturer BMS
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2024
Expected Registration May 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Primary completion (estimated): 30 september 2026.

Therapeutic value

Current treatment options Sorafenib, regorafenib
Therapeutic value Possibly no place in the treatment regimen
Substantiation OS: 23.7 mo with NIVO + IPI versus 20.6 mo with LEN/SOR (HR, 0.79; 95% CI, 0.65–0.96) (1,2). Voldoet niet aan PASKWIL-criteria.
References NCT04039607 (CA2099DW) (1); Robert Galle et al. JCO. 2024 (2).

Expected patient volume per year

Patient volume

< 324

Market share is generally not included unless otherwise stated.
References NKR 2024 (1).
Additional remarks In 2022 werden er 324 patiënten met hepatocellulair carcinoom gediagnosticeerd, stadium III en IV (1).

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.