WARNING: SERIOUS INFUSION REACTIONS and CARDIOPULMONARY ARREST
Infusion Reactions: Serious infusion reactions occurred with the administration of Erbitux in approximately 3% of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. [See Warnings and Precautions
, Adverse Reactions (6)
.] Immediately interrupt and permanently discontinue Erbitux infusion for serious infusion reactions. [See Dosage and Administration
, Warnings and Precautions
Cardiopulmonary Arrest: Cardiopulmonary arrest and/or sudden death occurred in 2% of patients with squamous cell carcinoma of the head and neck treated with Erbitux and radiation therapy in Study 1 and in 3% of patients with squamous cell carcinoma of the head and neck treated with European Union (EU)-approved cetuximab in combination with platinum-based therapy with 5-fluorouracil (5-FU) in Study 2. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux administration. [See Warnings and Precautions (5.2, 5.6)
, Clinical Studies
Erbitux® (cetuximab) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.
Erbitux is a sterile, clear, colorless liquid of pH 7.0 to 7.4, which may contain a small amount of easily visible, white, amorphous cetuximab particulates. Erbitux is supplied at a concentration of 2 mg/mL in either 100 mg (50 mL) or 200 mg (100 mL), single-use vials. Cetuximab is formulated in a solution with no preservatives, which contains 8.48 mg/mL sodium chloride, 1.88 mg/mL sodium phosphate dibasic heptahydrate, 0.41 mg/mL sodium phosphate monobasic monohydrate, and Water for Injection, USP.
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Erbitux® is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. [See Clinical Studies
Erbitux is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. [See Clinical Studies
Erbitux, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed. [See Clinical Studies
K-Ras Mutation-negative, EGFR-expressing Colorectal Cancer
Erbitux is indicated for the treatment of K-Ras mutation-negative (wild-type), epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use [see Dosage and Administration
, Warnings and Precautions
, Clinical Studies
- in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for the 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. [See Warnings and Precautions
, Clinical Pharmacology
, Clinical Studies
Limitation of Use: Erbitux is not indicated for treatment of K-Ras mutation-positive colorectal cancer [see Warnings and Precautions
, Clinical Studies
Media Articles Related to Erbitux (Cetuximab)
Cetuximab Continuation After CRC Progression May Up PFS
Source: Medscape Hematology-Oncology Headlines [2016.07.22]
Dr David Kerr reports on a phase 2 study suggesting that continuation of cetuximab after progression may improve progression-free survival in patients with metastatic colorectal cancer.
Genetic cause of 15 percent of colorectal cancer diagnoses identified
Source: Colorectal Cancer News From Medical News Today [2016.07.20]
Findings open up 'precision medicine' approach to prevention, diagnosis and treatment.
Internal radiation therapy: Better response in metastatic colorectal cancer patients
Source: Cancer / Oncology News From Medical News Today [2016.07.10]
New analysis shows patients with metastatic colorectal cancer treated with radiation therapy show better response than those receiving chemotherapy alone.
Colorectal cancer: Pivotal Phase III data for Xilonix presented
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.07.05]
XBiotech Inc., developer of next-generation True Human™ antibody therapies, has presented positive results from a pivotal Phase III trial of Xilonix™, the company's lead monoclonal...
Anti-PD-L1 immunotherapy shows response in microsatellite-stable metastatic colorectal cancer in combination with MEK inhibition
Source: Colorectal Cancer News From Medical News Today [2016.07.04]
Anti-PD-L1 immunotherapy may achieve a response in patients with microsatellite-stable metastatic colorectal cancer if combined with a MEK inhibitor, according to phase I data presented at the ESMO...
Published Studies Related to Erbitux (Cetuximab)
Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407. [2011.08.10]
PURPOSE: Cancer and Leukemia Group B conducted a randomized phase II trial to investigate two novel chemotherapy regimens in combination with concurrent thoracic radiation therapy (TRT)... CONCLUSION: The combination of pemetrexed, carboplatin, and TRT met the prespecified criteria for further evaluation. This regimen should be studied further in patients with locally advanced unresectable nonsquamous NSCLC.
Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. [2011.07]
BACKGROUND: The randomized phase II OPUS (Oxaliplatin and Cetuximab in First-Line Treatment of Metastatic Colorectal Cancer) study showed that tumor KRAS mutation status was predictive for outcome in patients receiving cetuximab plus FOLFOX-4 (oxaliplatin/5-fluorouracil/folinic acid) as first-line therapy for metastatic colorectal cancer (mCRC)... CONCLUSIONS: These results confirm the efficacy of cetuximab plus FOLFOX-4 in the first-line treatment of patients with KRAS wild-type mCRC and confirm KRAS mutation status as an effective predictive biomarker. The small number of tumors with BRAF mutations precluded the drawing of definitive conclusions concerning the predictive or prognostic utility of this biomarker.
Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial. [2011.06.18]
BACKGROUND: In the Medical Research Council (MRC) COIN trial, the epidermal growth factor receptor (EGFR)-targeted antibody cetuximab was added to standard chemotherapy in first-line treatment of advanced colorectal cancer with the aim of assessing effect on overall survival... INTERPRETATION: This trial has not confirmed a benefit of addition of cetuximab to oxaliplatin-based chemotherapy in first-line treatment of patients with advanced colorectal cancer. Cetuximab increases response rate, with no evidence of benefit in progression-free or overall survival in KRAS wild-type patients or even in patients selected by additional mutational analysis of their tumours. The use of cetuximab in combination with oxaliplatin and capecitabine in first-line chemotherapy in patients with widespread metastases cannot be recommended. FUNDING: Cancer Research UK, Cancer Research Wales, UK Medical Research Council, Merck KGgA. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. [2011.05.20]
PURPOSE: The addition of cetuximab to irinotecan, fluorouracil, and leucovorin (FOLFIRI) as first-line treatment for metastatic colorectal cancer (mCRC) was shown to reduce the risk of disease progression and increase the chance of response in patients with KRAS wild-type disease. An updated survival analysis, including additional patients analyzed for tumor mutation status, was undertaken... CONCLUSION: The addition of cetuximab to FOLFIRI as first-line therapy improves survival in patients with KRAS wild-type mCRC. BRAF tumor mutation is an indicator of poor prognosis.
Cetuximab therapy for head and neck squamous cell carcinoma: a systematic review of the data. [2011.05]
CONCLUSION: Early evidence has shown cetuximab to be effective in the treatment of HNSCC, and it should be used to enhance, but not replace, current treatment paradigms until further phase III data are available.
Clinical Trials Related to Erbitux (Cetuximab)
Phase 1 and 2 Study of PX-866 and Cetuximab [Completed]
The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a
cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of
PX-866 to be given in combination with cetuximab will be determined in patients with
incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase
2 part of the study is a randomized evaluation of the antitumor activity and safety of
PX-866 in combination with cetuximab versus cetuximab alone in patients with either
incurable metastatic CRC who have a history of progression or recurrence following prior
irinotecan and oxaliplatin containing regimens or are intolerant of irinotecan (Group 1) or
incurable progressive, recurrent or metastatic SCCHN (Group 2).
An Observational Study of Erbitux� in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment [Terminated]
This is an observational, non-interventional, uncontrolled, multicentric safety study in
subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat
sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data
related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35
institutions from the start of treatment with Erbitux until progressive disease,
Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever
Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442) [Completed]
The purpose of this study is to evaluate the response of the tumor to the treatment regimen
that will be used in this study. This study will also test the safety of cetuximab (C225),
given with chemotherapy and radiation therapy. We also want to see what effects (good and
bad) cetuximab, chemotherapy, and radiation therapy have head & neck cancer.
C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways
that lead to tumor cell growth. In prior studies with head & neck cancer patients, C225 has
delayed tumor growth and provided relief of symptoms in some patients.
Regorafenib and Cetuximab in Patients With Advanced Malignancy [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the
combination of regorafenib and cetuximab that can be given to patients with advanced solid
tumors. The safety and effectiveness of this drug combination will also be studied.
Bevacizumab, Temsirolimus, Valproic Acid, Cetuximab [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of Avastin
(bevacizumab) and Torisel (temsirolimus) that can be given in combination with either
valproic acid or cetuximab to patients with advanced cancer that is refractory. The safety
of this drug combination will also be studied.
Bevacizumab is designed to block the growth of blood vessels, which may help to slow or
block the growth of cancer.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells
Valproic acid is an anti-seizure drug that may be able to activate tumor-fighting genes,
causing cancer cells to die.
Cetuximab is designed to block a certain protein, called EGFR, that is thought to cause
cancer cells to grow. This may cause cancer cells to die.
Reports of Suspected Erbitux (Cetuximab) Side Effects
Infusion Related Reaction (62),
Acne (48), more >>
Page last updated: 2016-07-22