DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Erbitux (Cetuximab) - Summary

 

-- advertisement --

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.

ERBITUX NEWS HIGHLIGHTS

Media Articles Related to Erbitux (Cetuximab)

ERBITUX(R) Phase 3 BMS-099 Lung Cancer Study Secondary Endpoint Update: Overall Survival Results Announced
Source: Cancer / Oncology News From Medical News Today [2008.09.01]

Merck Serono Receives European Approval For Broader Usage Of Erbitux In Metastatic Colorectal Cancer Including 1st-Line Treatment
Source: Colorectal Cancer News From Medical News Today [2008.07.23]

ImClone updates data from lung cancer trial (Reuters)
Source: Y! Health News Search RSS Feed [2008.08.29]

Study Confirms Colorectal Cancer Screening Should Start At Age 50
Source: Health News from Medical News Today [2008.09.04]

PET Scans Lead To Treatment Changes In Majority Of Colorectal Cancer Patients
Source: Colorectal Cancer News From Medical News Today [2008.09.04]

more>>

Published Studies Related to Erbitux (Cetuximab)

A brief report on the safety study of induction chemotherapy followed by synchronous radiotherapy and cetuximab in stage III non-small cell lung cancer (NSCLC): SCRATCH study. [2008.06]

EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. [2008.05.10]

A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity. [2008.04]

Dual inhibition of the epidermal growth factor receptor with cetuximab, an IgG1 monoclonal antibody, and gefitinib, a tyrosine kinase inhibitor, in patients with refractory non-small cell lung cancer (NSCLC): a phase I study. [2008.03]

Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. [2008.02]

more>>

Clinical Trials Related to Erbitux (Cetuximab)

Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer [Active, not recruiting]

Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer [Active, not recruiting]

Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Pancreatic Cancer [Suspended]

Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors [Completed]

FLOX in Combination With Cetuximab in First-Line Treatment of Colorectal Cancer [Active, not recruiting]

more>>

Page last updated: 2008-09-04

-- advertisement -- The American Red Cross

We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2008