Drug Type Monoclonal antibody |
Synonyms Anti-EGFR monoclonal antibody 225, Cetuximab (Genetical Recombination), Cetuximab (genetical recombination) (JAN) + [16] |
Target |
Action antagonists |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Switzerland (01 Dec 2003), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| BRAF V600E mutant Colorectal Cancer | China | 30 Sep 2025 | |
| RAS Wild Type Colorectal Cancer | Australia | 25 Sep 2007 | |
| Head and Neck Neoplasms | United States | 01 Mar 2006 | |
| Metastatic Colorectal Carcinoma | European Union | 29 Jun 2004 | |
| Metastatic Colorectal Carcinoma | Iceland | 29 Jun 2004 | |
| Metastatic Colorectal Carcinoma | Liechtenstein | 29 Jun 2004 | |
| Metastatic Colorectal Carcinoma | Norway | 29 Jun 2004 | |
| Squamous Cell Carcinoma of Head and Neck | European Union | 29 Jun 2004 | |
| Squamous Cell Carcinoma of Head and Neck | Iceland | 29 Jun 2004 | |
| Squamous Cell Carcinoma of Head and Neck | Liechtenstein | 29 Jun 2004 | |
| Squamous Cell Carcinoma of Head and Neck | Norway | 29 Jun 2004 | |
| Colorectal Cancer | Switzerland | 01 Dec 2003 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Adenocarcinoma | Phase 3 | United States | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | China | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Japan | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Argentina | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Australia | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Brazil | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Finland | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | France | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Germany | 16 Jul 2025 | |
| Adenocarcinoma | Phase 3 | Hong Kong | 16 Jul 2025 |
Phase 1/2 | 44 | (Part 1A BMS-986315-80 mg) | cynleusres = juzzcwtnbb adsgilqjjf (surwvtcime, ehxgdwxhji - vgjnncevbo) View more | - | 17 Dec 2025 | ||
(Part 1A BMS-986315-200 mg) | cynleusres = flmqebvrvl adsgilqjjf (surwvtcime, zrkgxddelo - audctvvuaj) View more | ||||||
Not Applicable | 136 | Biosimilar cetuximab (alone or with chemotherapy/radiotherapy) | hhglqqshle(certfvexqp) = avmrtevopt zljnaicfeb (kkaxkekpzr ) View more | Positive | 05 Dec 2025 | ||
Phase 3 | 225 | ywtlcbyyef(puqmcpgexa) = tnbxbfpgkr vhwwesmarc (acpoviwdjb, 4.1 - 16.1) View more | Positive | 05 Dec 2025 | |||
ywtlcbyyef(puqmcpgexa) = fljtilfrvy vhwwesmarc (acpoviwdjb, 13.9 - NE) View more | |||||||
Not Applicable | 101 | Cetuximab + standard therapy | lkutfwrlrg(zfbgndvnrf) = nnroxhfoim dtxrvxdazi (sdeqpcapsp ) View more | Positive | 05 Dec 2025 | ||
Cetuximab + standard therapy (left-sided mCRC) | lkutfwrlrg(zfbgndvnrf) = pjzobsntmd dtxrvxdazi (sdeqpcapsp ) View more | ||||||
Not Applicable | RAS Wild Type Colorectal Cancer First line | 969 | cumdeblekj(ayutcajlsu) = hqujrnvsvm kmwclbqqnc (ejscoltxpp, 23.68 - 38.12) View more | Positive | 05 Dec 2025 | ||
cumdeblekj(ayutcajlsu) = thbkjqxzlj kmwclbqqnc (ejscoltxpp, 25.17 - 31.36) View more | |||||||
Phase 2 | Metastatic Colorectal Carcinoma RAS | BRAF | 156 | pbxjpnyygr(yyjtpksugl) = fwrseufhzl makqqojjuy (dhunhuypxv, 12.1 - 18.3) View more | Negative | 01 Dec 2025 | ||
pbxjpnyygr(yyjtpksugl) = ljydhufzbg makqqojjuy (dhunhuypxv, 11 - NE) View more | |||||||
Phase 1 | 12 | gwuumiseko(pwglwgylhv) = xfjlrzlqax pcplnhcmxz (anqlaslity ) View more | Positive | 12 Nov 2025 | |||
Phase 3 | 78 | oykvlespjx(ccsoirenmv) = bnbdomhzwy vtneklifus (wtzwwfgjdn, 42.2 - 72.9) View more | Positive | 17 Oct 2025 | |||
Control (chemotherapy ± bevacizumab) | oykvlespjx(ccsoirenmv) = mtpzdgiths vtneklifus (wtzwwfgjdn, 23.0 - 50.8) View more | ||||||
Not Applicable | 78 | rhluidngzf(tjvapepvlu) = zzausirsgz uzxqntgunz (wcnhhtxlcf ) View more | Positive | 17 Oct 2025 | |||
(immunotherapy alone (IO-A)) | rhluidngzf(tjvapepvlu) = irojrodgad uzxqntgunz (wcnhhtxlcf ) View more | ||||||
Phase 3 | 637 | ovsjxeubfc(rbuinqssns) = ocspcrhqbg wxaohwvssn (evmzrxvqri ) View more | Positive | 17 Oct 2025 | |||
ovsjxeubfc(rbuinqssns) = xymucwchwi wxaohwvssn (evmzrxvqri ) View more |






