YAbS







Cetuximab Approved Naked monospecific

Antibody Information

Entry ID 77
INN Cetuximab
Status Approved
Drug code(s) IMC-C225, C-225
Brand name Erbitux
mAb sequence source mAb chimeric
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG1
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) EGFR
Indications of clinical studies Head and neck cancer, colorectal, non-small cell lung cancer
Primary therapeutic area Cancer

Development stage information

Phase lengths*
*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).
Most advanced stage of development (global) Approved EU, US, Japan, Australia
Status Active
Start of clinical phase (IND filing or first Phase 1) November 15, 1994
Start of Phase 2 May 15, 1995
Start of Phase 3 March 09, 1999
Date BLA/NDA submitted to FDA August 14, 2003
Year of first approval (global) 2003
Date of first US approval February 12, 2004
INN, US product name Cetuximab
US or EU approved indications Colorectal cancer, head and neck cancer

Company information

Company Imclone Systems
Licensee/Partner Eisai, Cambridge Antibody Technology, Basf Pharma
Comments about company or candidate First approved in Switzerland on Dec 1, 2003
Full address of company 180 Varick Street, 6th Floor New York, NY 10014, United States
North America
United States of America
https://pitchbook.com/profiles/company/41262-76#overview

Description/comment

None

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None