Extended indication Extension of indication for Opdivo to include adjuvant treatment of adults with muscle invasive urot
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Bladder cancer
Extended indication Extension of indication for Opdivo to include adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC.
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)
Submission date March 2021
Expected Registration January 2022
Orphan drug No
Registration phase Registration application pending
Additional comments Voor nivolumab is er een financieel arrangement afgesloten met het Ministerie van VWS (lopend tot 1 januari 2024). Het verlengde financieel arrangement voor nivolumab heeft mede betrekking op alle (toekomstige) bewezen effectieve indicaties van nivolumab.

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.