Expand all sections

Nivolumab

Opdivo

Extended indication Metastatic colorectal carcinoma with mismatch-repair deficient (dMMR) microsatellite instability–hig
Therapeutic value No judgement

Product

Active substance Nivolumab
Domain Oncology and Hematology
Main indication Colon cancer
Extended indication Metastatic colorectal carcinoma with mismatch-repair deficient (dMMR) microsatellite instability–high (MSI-H).
Proprietary name Opdivo
Manufacturer BMS
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Financieel arrangement van toepassing op alle indicaties.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2017
Expected Registration April 2018
Orphan drug No
Additional remarks Dit is een indicatie-uitbreiding.

Therapeutic value

Current treatment options Concurrentie van Pembrolizumab en ander PD1 en PDL-1 remmers
Therapeutic value No judgement

Expected patient volume per year

Patient volume

< 156

Market share is generally not included unless otherwise stated.
References NKR; Zoran et al. Familial Cancer 15 (2016): 405–412.
Additional remarks 3115 patienten met CRC stadium 4 (NKR 2015). 15% van de CRC patienten heeft MSI-H (Zoran et al. Familial Cancer 15 (2016): 405–412.). Expertopinie: 5% MSI-H is realistisch.

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.