Extended indication Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patien
Registration phase Positive CHMP opinion

Product

Active substance Cetuximab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Colon cancer
Extended indication Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patients who have received prior systemic therapy.
Proprietary name Erbitux
Manufacturer Merck
Portfolio holder Merck
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Anti-EGFR monoklonaal antilichaam

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2026
Expected Registration July 2026
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in mei 2026.

Therapeutic value

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information