Expand all sections

Nivolumab

Opdivo

Extended indication Extension of indication to include OPDIVO for the treatment of patients with resectable stage II-III
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of indication to include OPDIVO for the treatment of patients with resectable stage II-IIIB non-small cell lung cancer
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 January 2024
Expected Registration October 2024
Orphan drug No
Registration phase Registration application pending
Additional remarks NCT04025879

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.