Cetuximab

(Erbitux®)

Cetuximab

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 100 mg/50 mL [2 mg/mL] or 200 mg/100 mL [2 mg/mL])
Drug ClassEpidermal growth factor receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
  • Indicated for the treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.
  • Indicated for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy
  • Indicated for the treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test: in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
  • Indicated for the treatment of BRAF V600E mutation-positive metastatic colorectal cancer (CRC): in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

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Summary
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  • Erbitux (cetuximab) is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy; the treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil; the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy; the treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test: in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan; and the treatment of BRAF V600E mutation-positive metastatic colorectal cancer (CRC) in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • Metastatic Colorectal Cancer (mCRC): The combination of FOLFOXIRI and cetuximab improved the objective response rate (ORR) to 85% and the R0 resection rate to 42%, with median progression-free survival (PFS) ranging from 9.5 to 15.5 months, and median overall survival (OS) from 24.7 to 37 months. High ORR (82%) and R0 resection rate (59%) were also observed with triplet chemotherapy and anti-EGFR therapy, with median PFS between 9.5 and 17.8 months, and OS between 24.7 and 62.5 months.
  • Head and Neck Squamous Cell Carcinoma (HNSCC): Cetuximab with radiotherapy (ExRT) showed less favorable outcomes in overall survival (OS), disease-specific survival (DSS), locoregional control (LRC), and progression-free survival (PFS) compared to platinum-based chemotherapy with radiotherapy (ChRT). Concurrent cisplatin with radiotherapy (CRT) provided better OS, PFS, LRC, and distant metastasis-free survival (DMFS) compared to cetuximab with radiotherapy (BRT).
  • Non-Small Cell Lung Cancer (NSCLC): EGFR-targeted therapies (erlotinib, gefitinib, afatinib, and icotinib) demonstrated increased tumor response rates and prolonged PFS compared to cytotoxic chemotherapy in EGFR mutation-positive NSCLC patients.
  • Diarrhea and neutropenia were the most common grade 3 and 4 adverse events in patients with metastatic colorectal cancer (mCRC) treated with the FOLFOXIRI + anti-EGFR antibody regimen.
  • Cetuximab-based chemotherapy in mCRC increased the risk of dermatological (e.g., rash) and renal adverse events, while bevacizumab-based chemotherapy was associated with a higher risk of cardiovascular events such as hypertension and arrhythmia.
  • In patients with head and neck squamous cell carcinoma (HNSCC), cetuximab combined with radiotherapy (ExRT) resulted in higher rates of mucositis, skin toxicity, and infection compared to platinum-based chemotherapy with radiotherapy (ChRT), but lower incidence of anemia, leukocytopenia, neutropenia, nausea/vomiting, and renal toxicity.
  • Studies focused on molecularly unselected and unresectable metastatic CRC patients, with specific subgroup considerations for RAS wild-type mCRC, human papillomavirus-positive locally advanced HNSCC, and predominantly Asian EGFR mutation-positive NSCLC patients, revealing different safety profiles for bevacizumab and cetuximab-based chemotherapy in RAS wild-type mCRC, inferior disease-specific survival and locoregional control for ExRT compared to ChRT in HPV-positive HNSCC, and increased progression-free survival and tumor response rates for EGFR-targeted therapies in EGFR mutation-positive NSCLC.

Product Monograph / Prescribing Information

Document TitleYearSource
Erbitux (cetuximab) Prescribing Information.2021Eli Lilly and Company., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Triplet-drug chemotherapy combined with anti-EGFR antibody as an effective therapy for patients with initially unresectable metastatic colorectal cancer: a meta-analysis.2023World journal of Surgical Oncology
Tolerability on serious adverse events of first-line bevacizumab and cetuximab for Ras wild-type metastatic colorectal cancer: a systematic review and meta-analysis.2022Healthcare
A comparison of panitumumab and cetuximab in the treatment of KRAS wild-type metastatic colorectal cancer: a systematic review and meta-analysis.2022Immunopharmacology and Immunotoxicology
Efficacy and safety of Cetuximab dosing (biweekly vs weekly) in patients with KRAS wild-type metastatic colorectal cancer: a meta-analysis.2022The Oncologist
Efficacy and safety of triplet chemotherapy plus anti-EGFR agents in metastatic colorectal cancer: a systematic review and meta-analysis. 2022World Journal of Surgical Oncology
Safety assessment on serious adverse events of targeted therapeutic agents prescribed for RAS wild-type metastatic colorectal cancer: Systematic review and network meta-analysis.2022International Journal of Environmental Research and Public Health
First-line treatment of advanced epidermal growth factor receptor (EGFR) mutation positive non-squamous non-small cell lung cancer.2021The Cochrane Database of Systematic Reviews
Comparison between biweekly and weekly cetuximab in patients with metastatic colorectal cancer: a meta-analysis.2020Anticancer Research
Comparative efficacy and safety of radiotherapy/cetuximab versus radiotherapy/chemotherapy for locally advanced head and neck squamous cell carcinoma patients: a systematic review of published, primarily non-randomized, data.2020Therapeutic Advances in Medical Oncology
Concurrent cisplatin or cetuximab with radiotherapy in patients with locally advanced head and neck squamous cell carcinoma; a meta-analysis.2020Medicine

Clinical Practice Guidelines

Document TitleYearSource
Treatment of metastatic colorectal cancer: ASCO guideline.2022Journal of Clinical Oncology