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Topic: Erbitux

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	ACS :: Erbitux Approved for Colorectal Cancer
		Erbitux, developed by ImClone Systems Incorporated, is the first monoclonal antibody approved for treatment of colorectal cancer.
		Erbitux was first submitted for approval in 2001, but the FDA rejected it, saying the application lacked important information about the safety and effectiveness of the drug.
		Erbitux alone caused tumors to shrink in nearly 11% of patients, and delayed tumor growth by 1.5 months.
	www.cancer.org /docroot/NWS/content/NWS_1_1x_Erbitux_Approved_for_Colorectal_Cancer.asp (394 words)

	Cetuximab - Wikipedia, the free encyclopedia
		Cetuximab (Erbitux®) is a chimeric monoclonal antibody given by intravenous injection for treatment of metastatic colorectal cancer and head and neck cancer.
		A new clinical trial and FDA filing prepared by Imclone's partner Merck KGaA ("German Merck," not to be confused with the US company of similar name) resulted in an FDA approval of the drug in 2004 for use in colon cancer.
		Erbitux® is one of the most expensive drugs available, costing over $17,000 per month for the average dose.
	en.wikipedia.org /wiki/Erbitux (516 words)

	Business Wire Business News: Clinical Data Suggest ERBITUX(R) Recruits the Body's Immune System to Help Fight Cancer ... (Site not responding. Last check: 2007-11-01)
		ERBITUX (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.
		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.
		ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy.
	news.moneycentral.msn.com /provider/providerarticle.asp?Feed=BW&Date=20060604&ID=5768707 (1939 words)

	Erbitux Information from Drugs.com
		Erbitux is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.
		Erbitux is used to treat cancers of the colon and rectum.
		Erbitux is given as an injection through a needle placed into a vein.
	www.drugs.com /erbitux.html (1331 words)

	Bristol-Myers Squibb - Newsroom - Press Release - FDA Approves ERBITUX® (Cetuximab) For Treatment Of Head And Neck ... (Site not responding. Last check: 2007-11-01)
		With this approval, ERBITUX is now indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed.
		ERBITUX was granted approval by SwissMedic in December 2005 for use in combination with radiation in the treatment of patients with previously untreated advanced head and neck cancer.
		ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1).
	www.bms.com /news/press/data/fg_press_release_6232.html (2169 words)

	Drug Development Technology - Erbitux (Cetuximab) Investigational Biological Cancer Therapy
		Regulatory approval for the use of Erbitux in metastatic colorectal cancer was obtained in 2004.
		Erbitux binds to the extracellular domain of EGFR on the tumour cell, thereby inhibiting receptor-associated tyrosine kinase.
		In the Erbitux head and neck cancer trial, there was no increase in the rate of mucositis between the combination and control treatment arms (55% vs. 52% respectively).
	www.drugdevelopment-technology.com /projects/erbitux (987 words)

	AFH LIBRARY - Bush, Colorectal Cancer and Erbitux. (Site not responding. Last check: 2007-11-01)
		Erbitux is considered a last-ditch treatment for cancers of the colon or rectum, which have spread to other parts of the body.
		Erbitux was the latest beneficiary of FDA's accelerated approval program, which allows the agency to approve products for the treatment of cancer and other serious diseases based on what they consider to be "early evidence" of effectiveness.
		Erbitux is one in a generation of so-called "targeted" therapies for cancer that emerged in the 1990s.
	www.alkalizeforhealth.net /Lbusherbitux.htm (4599 words)

	Latest Data on Marked Survival Improvement with Erbitux® in Head and Neck Cancer
		Erbitux, a monoclonal antibody (or protein), is designed to bind to the EGFR and inhibit the receptor’s effects on cellular replication.
		Erbitux is currently FDA-approved in combination with irinotecan for the treatment of colorectal cancer that has stopped responding to irinotecan-based chemotherapy.
		Erbitux is currently being evaluated in clinical trials for the treatment of various types of cancer.
	www.oralcancerfoundation.org /news/story.asp?newsId=1040 (689 words)

	FDA Approves Erbitux® For Treatment of Head and Neck Cancer
		The indication is for the use of Erbitux in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck, or as a single agent in recurrent or metastatic squamous cell carcinoma of the head and neck that has progressed following prior platinum-based chemotherapy.
		Erbitux, a monoclonal antibody (or protein), has been developed in a laboratory with the purpose of binding to the EGFR and inhibiting the receptor’s effects on cellular replication.
		Erbitux was previously FDA-approved to be used in combination with Camptosar® (irinotecan) for the treatment of colorectal cancer that has stopped responding to irinotecan-based chemotherapy.
	patient.cancerconsultants.com /news.aspx?id=36394 (771 words)

	Questions and Answers on Erbitux (cetuximab)
		Erbitux is a monoclonal antibody that targets a protein called the epidermal growth factor receptor (EGFR).
		Erbitux is believed to interfere with the growth of cancer cells by binding to EGFR so that the normal (natural) epidermal growth factors cannot bind and stimulate the cells to grow.
		Erbitux is a new type of cancer drug used to treat cancer of the colon or rectum that has spread to other parts of the body.
	www.fda.gov /cder/drug/infopage/erbitux/erbituxQA.htm (377 words)

	WebWire® \| FDA Accepts Erbitux® (Cetuximab) sBLA Submission For The Treatment Of Squamous Cell Carcinoma Of The ...
		The application seeks approval for use of Erbitux in combination with radiation for locally or regionally advanced head and neck cancer, and as monotherapy in patients with recurrent and/or metastatic disease where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate.
		The effectiveness of Erbitux for the treatment of colorectal cancer is based on objective response rates.
		Erbitux binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.
	www.webwire.com /ViewPressRel.asp?aId=5136 (1001 words)

	Erbitux (Cetuximab) Approved for Launch in European Union (Site not responding. Last check: 2007-11-01)
		Erbitux is well tolerated in combination with chemotherapy and does not increase the typical side effects experienced with irinotecan.
		In May 2004, Erbitux was also approved in Argentina and Mexico as well as in June 2004 in Chile, for use in combination with irinotecan or as a single agent in patients with EGFR-expressing metastatic CRC after failure of irinotecan-including cytotoxic therapy.
		In February 2004, the FDA approved Erbitux in the USA for use in combination with irinotecan for the treatment of patients with EGFR-expressing, metastatic CRC who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic CRC who are intolerant to irinotecan-based chemotherapy.
	www.pslgroup.com /dg/24489A.htm (1008 words)

	WJLA - Erbitux Approved for Head, Neck Cancer (Site not responding. Last check: 2007-11-01)
		Erbitux is made by ImClone Systems Inc. and distributed by Bristol-Myers Squibb Co. both of which are based in New York.
		Erbitux, formally known as cetuximab, was the drug at the center of the ImClone Systems stock scandal that sent Martha Stewart and ImClone founder Sam Waksal to prison.
		The FDA said it approved the new use for the drug based on a study that showed Erbitux, in combination with radiation therapy, prolonged the lives of head and neck cancer patients by 20 months compared to treatment with radiation alone.
	www.wjla.com /headlines/0306/307180.html (356 words)

	Newly Approved Drug Therapies (850): Erbitux (cetuximab), Imclone, Bristol-Myers Squibb
		Erbitux (cetuximab) for injection is a monoclonal antibodyt hat targets and inhibits epidermal growth factor receptor (EGFr).
		Erbitux is indicated, in combination with irinotecan, for the treatment of EGFR-expressing, metastatic colorectal cancer in patients who are refractory to irinotecan-based chemotherapy.
		Erbitux is a recombinant, human/mouse chimeric monoclonal antibody.
	www.centerwatch.com /patient/drugs/dru850.html (685 words)

	FDA OKs Drug for Head & Neck Cancer
		Erbitux blocks the effect of a major growth factor that is responsible for causing cancers to grow.
		Erbitux is also used in other cancers, such as colorectal cancer.
		Erbitux helped to shrink the patients' tumors after the tumors no longer responded to platinum-based therapy, the standard treatment for patients with this difficult-to-treat disease.
	www.webmd.com /content/Article/119/113328.htm?pagenumber=2 (266 words)

	UPHS News: Penn Researchers Determine Structure of Binding Site of Colon-Cancer Drug and Its Protein Target (Site not responding. Last check: 2007-11-01)
		Erbitux works by binding to a protein on the surface of cancer cells, thereby halting excessive cell growth that leads to tumors.
		As is the case in Erbitux, “the protein EGFR needs to not only be present on tumors but it needs to be there and be active,” says Ferguson.
		The researchers’ hope is that with these new insights into Erbitux’s action and structure, treatments for colorectal cancer and other epithelial cancers will be expanded, thereby contributing to the creation of future generations of improved cancer drugs.
	www.uphs.upenn.edu /news/News_Releases/apr05/Erbituxconfig_test.htm (692 words)

	New Drugs for Treating Colorectal Cancer: Avastin and Erbitux
		Erbitux is believed to interfere with the growth of cancer cells by binding to EGFR so that the normal epidermal growth factors cannot bind and stimulate the cells to grow.
		Erbitux was approved in February 2004 to treat colorectal cancers that have spread to other parts of the body (metastasized).
		Erbitux is administered intravenously either alone or with a cancer chemotherapy drug called Camptosar.
	www.webmd.com /content/article/82/97354 (513 words)

	ACS :: Erbitux Now Approved for Head and Neck Cancers
		Erbitux can now be given along with radiation as a first line therapy for people with early stage cancers of the oropharynx and hypopharynx or larynx that cannot be removed by surgery.
		The FDA also approved Erbitux for use by itself in patients whose head and neck cancer has spread and no longer responds to chemotherapy.
		The manufacturers said Erbitux should be used cautiously in people who have heart disease, congestive heart failure, or abnormal heart rhythms.
	www.cancer.org /docroot/NWS/content/NWS_1_1x_Erbitux_Now_Approved_for_Head_and_Neck_Cancers.asp (354 words)

	FDA Approves Erbitux for Colorectal Cancer
		Erbitux was approved under FDA's accelerated approval program, which allows FDA to approve products for cancer and other serious or life-threatening diseases based on early evidence of a product's effectiveness.
		The efficacy and safety of Erbitux alone or in combination with irinotecan were studied in a randomized, controlled trial with 329 patients and also in combination with irinotecan in 138 patients in which all patients received both drugs.
		Erbitux was further evaluated as a single agent in a third clinical trial with 57 patients.
	www.preferredconsumer.com /medical/articles/fda_approves_erbitux_colorectal_cancer.html (912 words)

	Scientific Data Presented at ASCO Annual Meeting Evaluating ERBITUX(TM) (Cetuximab) in Colorectal Cancer (Abstracts ...
		Investigators who conducted the four studies of ERBITUX for metastatic CRC presented the following data: Abstract #3510 Response rate and median overall survival results were presented from a Phase II study (IMCL-0144) of 346 patients with EGFR-expressing CRC that were refractory to chemotherapy with irinotecan and oxaliplatin.
		ERBITUX(TM) (Cetuximab) Approved Indication ERBITUX is approved by the FDA for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.
		ERBITUX Important Safety Information Severe infusion reactions, rarely fatal and characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension, have occurred (3%) with the administration of ERBITUX.
	www.prnewswire.com /cgi-bin/stories.pl?ACCT=105&STORY=/www/story/06-06-2004/0002187903 (1652 words)

	Bristol Myers-Squibb Company; ImClone Systems Incorporated :: MultiVu Video Feed: FDA Approves ERBITUX(R) (Cetuximab) ...
		ERBITUX was also approved for use alone to treat patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body and who have failed platinum-based chemotherapy.
		Other serious side effects associated with ERBITUX in combination with radiation therapy in patients with head and neck cancer were mouth sores (6%), skin irritation in the radiation area (3%), confusion (2%) and diarrhea (2%).
		NEWS: ERBITUX is the first FDA-approved therapy for head and neck cancer in more than thirty years and is the only monoclonal antibody approved for the treatment of patients with head and neck cancer.
	sev.prnewswire.com /medical-pharmaceuticals/20060301/NYW20302032006-1.html (793 words)

	erbitux drug information, erbitux side effects
		Erbitux is a monoclonal antibody that targets a protein called the epidermal...
		Erbitux is believed to interfere with the growth...
		Cetuximab (Erbitux®) is a chimeric monoclonal antibody given by intravenous injection for treatment of metastatic...
	www.drugs.com /sch/erbitux (476 words)

	RedOrbit - Health - ERBITUX(R) Data on Locoregional Control and Overall Survival in Phase III Head and Neck Cancer ... (Site not responding. Last check: 2007-11-01)
		The study demonstrated that the addition of ERBITUX to radiation resulted in a 9.5 month improvement in median duration of locoregional control, or the prevention of the spread of cancer beyond the head and neck region, and a 19.7 month improvement in median survival when compared to radiation alone; both results were statistically significant.
		Other serious adverse events associated with ERBITUX in clinical trials (n=774) were fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX plus irinotecan, 2% receiving ERBITUX as a single agent) and diarrhea (6% in patients receiving ERBITUX plus irinotecan, 0.2% with ERBITUX as a single agent).
		Additional common adverse events seen in patients receiving ERBITUX plus irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%) and headache (14%/26%).
	www.redorbit.com /news/health/306886/erbituxr_data_on_locoregional_control_and_overall_survival_in_phase/index.html?source=r_health (1359 words)

	Cover Story July/Aug 2003 (Site not responding. Last check: 2007-11-01)
		Erbitux is the flagship product of the embattled biotechnology firm ImClone Systems, Inc, which will produce and market the drug in combination with Bristol Meyers-Squibb.
		The science behind Erbitux is dense, but in essence the drug is a highly specific, chimerized, monoclonal antibody, initially designed for the treatment of irinotecan-refractory colorectal cancer.
		A new Phase III trial is also underway, examining the value of Erbitux with chemotherapy and with radiotherapy for the treatment of cancers of the head and neck.
	www.oncologynetguide.com /v4n4/coverstory.html (3326 words)

	Erbitux produces survival benefit in head and neck cancer - Pharmaceutical Business Review (Site not responding. Last check: 2007-11-01)
		A phase III study of ImClone Systems anticancer drug Erbitux in conjuction with radiation has shown that the drug significantly slowed the spread of head and neck cancer and also produced a considerable survival benefit in the patient population.
		The study demonstrated that the addition of the drug to radiation resulted in a 9.5 month improvement in median duration of locoregional control, or the prevention of the spread of cancer beyond the head and neck region, and a 19.7 month improvement in median survival when compared to radiation alone; both results were statistically significant.
		In addition, there was an advantage for the Erbitux regimen over radiation alone in the three year survival rates.
	www.pharmaceutical-business-review.com /article_news_print.asp?guid=E5ED5E6D-DA1C-4FDF-A266-604672B7BD80 (323 words)

	Bristol-Myers Squibb :: FDA Approves ERBITUX(R) (Cetuximab) for Treatment of Head and Neck Cancer (Site not responding. Last check: 2007-11-01)
		This is the second indicated tumor type for ERBITUX, previously approved by the FDA for use in combination with irinotecan for patients with EGFR- expressing metastatic colorectal cancer who are refractory to irinotecan therapy and as a single-agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan therapy.
		While the mechanism of ERBITUX' anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX.
		Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX as compared to none of 212 patients treated with radiotherapy alone.
	sev.prnewswire.com /biotechnology/20060301/NYW19602032006-1.html (2066 words)

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