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Erbitux (Cetuximab) - Summary

 
 



BOX WARNING


Infusion Reactions: Severe infusion reactions occurred with the administration of ERBITUX in approximately 3% of patients, rarely with fatal outcome (<1 in 1000). Approximately 90% of severe infusion reactions were associated with the first infusion of ERBITUX. Severe infusion reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension (see WARNINGS and ADVERSE REACTIONS). Severe infusion reactions require immediate interruption of the ERBITUX infusion and permanent discontinuation from further treatment. (See WARNINGS: Infusion Reactions and DOSAGE AND ADMINISTRATION: Dose Modifications.)

 

ERBITUX SUMMARY

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).

ERBITUX, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.

ERBITUX (Cetuximab) administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy.

The effectiveness of ERBITUX is based on objective response rates (see CLINICAL STUDIES). Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX.


See all Erbitux indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Erbitux (Cetuximab)

ESMO: Erbitux No Help in Esophageal Ca (CME/CE)
Source: MedPage Today Gastroenterology [2014.07.02]
(MedPage Today) -- Survival in esophageal cancer did not improve with the addition of cetuximab (Erbitux) to conventional chemoradiation, results of a randomized trial showed. The study was among several notable reports from the European Society for Medical Oncology World Congress on Gastrointestinal Cancer.

CRYSTAL analysis shows clinical benefit of Erbitux in RAS wild-type mCRC patients
Source: Colorectal Cancer News From Medical News Today [2014.05.19]
Merck Serono, the biopharmaceutical division of Merck, has announced new biomarker findings from a retrospective analysis of the completed Phase III study CRYSTAL that compared Erbitux®...

In KRAS wild-type MCRC, equivalent survival offered by cetuximab or bevacizumab with combi chemo
Source: Colorectal Cancer News From Medical News Today [2014.07.01]
For patients with KRAS wild-type untreated colorectal cancer, adding cetuximab or bevacizumab to combination chemotherapy offers equivalent survival, researchers said at the ESMO 16th World Congress...

New study data find Avastin® (bevacizumab) and cetuximab help patients with KRAS wild-type advanced bowel cancer live similar length of time
Source: Colorectal Cancer News From Medical News Today [2014.06.04]
CALGB 80405, a large, independent, phase III study, designed to assess the superiority in overall survival (OS) of cetuximab over Avastin® (bevacizumab) when combined with either FOLFOX or...

Phase III trial shows improved survival with TAS-102 in metastatic colorectal cancer refractory to standard therapies
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.06.30]
The new combination agent TAS-102 is able to improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers said at the...

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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.

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Clinical Trials Related to Erbitux (Cetuximab)

Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer [Active, not recruiting]
The purpose of the study is to determine in patients with Non Small Cell Lung Cancer refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy.

Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer [Active, not recruiting]
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.

Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Pancreatic Cancer [Suspended]
Eligible patients with pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine

Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors [Completed]
The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.

FLOX in Combination With Cetuximab in First-Line Treatment of Colorectal Cancer [Active, not recruiting]
The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.

more trials >>

Reports of Suspected Erbitux (Cetuximab) Side Effects

Rash (150)Diarrhoea (84)Dehydration (81)Dyspnoea (74)Nausea (70)Vomiting (62)Infusion Related Reaction (62)Stomatitis (61)Fatigue (50)Acne (48)more >>


Page last updated: 2014-07-02

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