Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | EGFR |
| Indications of clinical studies | Head and neck cancer, colorectal, non-small cell lung cancer |
| Primary therapeutic area | Cancer |
| 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 | 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 |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |