Version 2

Nivolumab

Medicine

Extended indication Extension of indication to include opdivo in combination with ipilimumab for the treatment of adults patients with mismatch repair deficient or micros
Therapeutic value Possible added value
Registration phase Positive CHMP opinion

Product

Active substance Nivolumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Colon cancer
Extended indication Extension of indication to include opdivo in combination with ipilimumab for the treatment of adults patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer and treatment of metastatic colorectal cancer after prior fluoropyrimidine‑based combination chemotherapy.
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
Particularity Unknown
ATMP No
Submission date April 2024
Expected Registration January 2025
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie november 2024

Therapeutic value

Therapeutic value Possible added value

This assessment does not indicate any potential inclusion in the package.
Substantiation De resultaten zijn veelbelovend. Met een mediane follow-up van 24,3 maanden liet NIVO + IPI een klinisch betekenisvolle en statistisch significante verbetering zien in PFS versus chemotherapie, met een vermindering van 79% in het risico op ziekteprogressie of overlijden (HR 0,21 [95% CI 0,14–0,32]; P < 0,0001) Er is nog geen OS data.
References NCT04008030 (Checkmate 8HW)

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 remarks 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

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information