Extended indication Extension of indication in combination with ipilimumab to include treatment of adult patients with m
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Nivolumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Colon cancer
Extended indication Extension of indication in combination with ipilimumab to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy;
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)
Submission date December 2020
Expected Registration July 2021
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in mei 2021. 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
Substantiation Op dit moment loopt de fase 3 studie nog. De fase 2 data is gepubliceerd in 2018. Hierin werd geconcludeerd dat nivolumab plus ipilimumab mogelijk effectiever is dan monotherapie.
Frequency of administration 2 times every 2 weeks
Dosage per administration 3mg/kg
References J Clin Oncol 2018 Mar 10;36(8):773-779; NCT02060188

Expected patient volume per year

Patient volume

127

Market share is generally not included unless otherwise stated.

References NKR 2018; Poynter et al. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3208-15.; Zhaohui Jin. Prognostic and Predictive Values of Mismatch Repair Deficiency in Non-Metastatic Colorectal Cancer. Cancers 2021.
Additional comments In 2018 waren er 1.929 patiënten met een coloncarcinoom en 622 patiënten met een rectum carcinoom in stadium 4. Dit zijn in totaal 2.551 patiënten. Er wordt verwacht dat ongeveer 5% hiervan in aanmerking zal komen voor behandeling. Dit betekent dat er naar verwachting 127 patiënten per jaar behandeld zullen worden.

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.