Drug Profile

Cetuximab - Eli Lilly and Company

Alternative Names: Anti-EGFR monoclonal antibody 225; C 225; ch 225; Erbitux; IMC-C225; LY-2939777

Latest Information Update: 03 Feb 2025

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At a glance

Originator University of California
Developer Array BioPharma; Bristol-Myers Squibb; Celldex Therapeutics Inc; Centre Jean Perrin; Eli Lilly; Eli Lilly and Company; Fudan University; Merck KGaA; National Cancer Institute (USA); New York University School of Medicine; Novartis; Pfizer; Pierre Fabre; Radiation Therapy Oncology Group; Roche; UNICANCER; University of Michigan Comprehensive Cancer Center
Class Antineoplastics; Immunotherapies; Monoclonal antibodies
Mechanism of Action Angiogenesis inhibitors; Antibody-dependent cell cytotoxicity; Epidermal growth factor receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Squamous cell cancer
New Molecular Entity Yes

Marketed Colorectal cancer; Head and neck cancer
Phase III Non-small cell lung cancer
Phase II Bladder cancer; Breast cancer; Gastric cancer; Malignant-mesothelioma; Rectal cancer; Squamous cell cancer
Phase I/II Adenoid cystic carcinoma; Solid tumours
Phase Unknown Oesophageal cancer
No development reported Pancreatic cancer; Prostate cancer

25 Jan 2025 Efficacy and adverse events data from the phase III BREAKWATER trial in Colorectal cancer released by Pfizer
22 Nov 2024 Cetuximab is still in phase III development for Colorectal cancer (Combination therapy, In adolescents, In the elderly, Late-stage disease, Metastatic disease, Second-line therapy or greater, In adults) in Ukraine, Argentina, Australia, Germany, India, South Africa, Mexico, China, Italy, New Zealand, Bulgaria, Japan, Canada, Spain, Taiwan, Norway, Brazil, Sweden, France, Czech Republic, Slovakia, Finland, United Kingdom, South Korea, Russia, Netherlands, Denmark, Poland and Belgium (IV) (NCT04607421) (EudraCT2020-001288-99)
19 Nov 2024 Discontinued - Phase-III for Non-small cell lung cancer (First-line therapy, Combination therapy, Late-stage disease, Inoperable/Unresectable, Newly diagnosed) in Canada (IV)

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