Nivolumab

Extended indication	Extension of indication to include OPDIVO in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC).
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 in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC).
Proprietary name	Opdivo
Manufacturer	BMS
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	March 2022
Expected Registration	January 2023
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

Additional remarks	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.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.