Cetuximab

Cetuximab
Monoclonal antibody

Type	Whole antibody
Source	Chimeric (mouse/human)
Target	EGF receptor
Clinical data
Trade names	Erbitux
AHFS/Drugs.com	Monograph
License data	EU EMA: Erbitux US FDA: Cetuximab
Pregnancy category	AU: D US: C (Risk not ruled out)
Routes of administration	intravenous
ATC code	L01XC06 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only UK: POM (Prescription only) US: ℞-only
Pharmacokinetic data
Biological half-life	114 hrs
Identifiers
CAS Number	205923-56-4^Y
DrugBank	DB00002^Y
ChemSpider	none
UNII	PQX0D8J21J^Y
KEGG	D03455^Y
ChEMBL	CHEMBL1201577^N
Chemical and physical data
Formula	C₆₄₈₄H₁₀₀₄₂N₁₇₃₂O₂₀₂₃S₃₆
Molar mass	145781.6 g/mol
^NY (what is this?)

Cetuximab (INN) is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion that is distributed under the trade name Erbitux in the U.S. and Canada by the drug company Bristol-Myers Squibb and outside the U.S. and Canada by the drug company Merck KGaA. In Japan, Merck KGaA, Bristol-Myers Squibb and Eli Lilly have a co-distribution.

In July 2009, the FDA approved cetuximab (Erbitux) for treatment of colon cancer with wild-type KRAS, since it had little or no effect in colorectal tumors harboring a KRAS mutation (this also applied to the EGFR antibody panitumumab) This was the first genetic test to guide treatment of cancer. In July 2012, the FDA approved a real time PCR companion diagnostic test for KRAS, the therascreen KRAS test.

Cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer (mCRC), in combination with chemotherapy, and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. The positive opinion from the European regulatory agency, the Committee for Medicinal Products for Human Use (CHMP), was received for mCRC 1st line use in May 2008.

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