Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 100 mg/50 mL [2 mg/mL] or 200 mg/100 mL [2 mg/mL]) |
| Drug Class | Epidermal growth factor receptor (EGFR) 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.
Latest News
Summary
- This summary is based on the review of 25 systematic review(s)/meta-analysis(es). [1-25]
- In locally advanced head and neck squamous cell carcinoma (LA HNSCC), cetuximab with radiotherapy improved locoregional control (LRC), overall survival (OS), and progression-free survival (PFS) compared to radiotherapy alone, with median OS ranging from 12.8 to 46 months. Cetuximab added to standard chemoradiation or combined with zalutumumab did not improve survival outcomes compared to chemoradiation alone.
- In HPV-positive oropharyngeal squamous cell carcinoma (HPV(+) OPSCC), cetuximab combined with radiotherapy led to significantly shorter OS and PFS, along with increased rates of local regional failure and distant metastasis, compared to cisplatin combined with radiotherapy.
- For metastatic colorectal cancer (mCRC), cetuximab in combination therapies improved health-related quality of life (HRQoL) compared to combination therapies without cetuximab. In RAS/KRAS wild-type patients, anti-epidermal growth factor receptor (EGFR) therapies, including cetuximab, provided benefits in objective response rate (ORR) and R0 resection rates, with median PFS between 9.5 and 15.5 months and OS between 24.7 and 37 months.
- In recurrent or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN), cetuximab combined with PD-1 inhibitors improved the objective response rate (ORR) and 1-year OS rate in HPV-negative head and neck squamous cell carcinoma (HNSCC) patients, while no significant effectiveness was observed in HPV-positive cases.
- In locally advanced (LA) HNSCC, cetuximab combined with radiotherapy (RT) increased occurrences of mucositis, skin toxicity, and infection, while showing lower incidences of anemia, leukocytopenia, neutropenia, nausea/vomiting, and renal toxicity compared to non-cetuximab treatments.
- For metastatic colorectal cancer (mCRC), cetuximab monotherapy was associated with fewer adverse events compared to combination therapy, though it presented higher risks of dermatological and renal toxicities. Bevacizumab showed lower dermatological and renal adverse events than cetuximab but higher cardiovascular risks.
- In HNSCC, cetuximab combined with PD-1 inhibitors resulted in increased grade 3 or higher toxicities when combined with radiotherapy.
- Cetuximab demonstrated improved outcomes in HPV-negative HNSCC when combined with PD-1 inhibitors, while patients with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) experienced shorter overall survival and progression-free survival with cetuximab plus radiotherapy compared to cisplatin plus radiotherapy; in metastatic colorectal cancer (mCRC), cetuximab yielded better response rates and resection outcomes in RAS/KRAS wild-type patients but showed no significant quality-of-life benefit for KRAS mutant patients.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Erbitux (cetuximab) Prescribing Information. | 2021 | Eli Lilly and Company., Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Treatment of Metastatic Colorectal Cancer: ASCO Guideline | 2023 | Journal of Clinical Oncology : Official Journal of the American Society of |