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	AstraZeneca's Iressa Failure Could Be Catching
		Iressa is a one of a new class of targeted cancer drugs and is currently under review by the Food and Drug Administration for use by itself in patients with advanced lung cancer.
		Iressa is one of AstraZeneca's most highly anticipated new drugs, which are supposed to help the pharmaceutical firm make up for the lost sales due to upcoming generic competition for its heartburn medicine, Prilosec.
		Iressa is already approved in Japan as a monotherapy, but has not yet been submitted to European drug regulators.
	www.thestreet.com /tech/adamfeuerstein/10038331.html (672 words)

	ACS :: Discovery Promises Better Use of Iressa for Lung Cancer
		A year after gefitinib (Iressa) was approved as a last resort for people with advanced non small-cell lung cancer, two studies published today solve the mystery of why the pill is dramatically effective for only about 10% of patients.
		A year after Iressa (gefitinib) was approved as a last resort for people with advanced non small-cell lung cancer, two studies published today may solve the mystery of why the pill is effective in only 10% to 15% of patients.
		The FDA approved Iressa in May 2003 for patients with advanced non-small cell lung cancer (NSCLC) whose tumors continued to grow despite standard chemotherapy treatment.
	www.cancer.org /docroot/nws/content/nws_1_1x_discovery_promises_better_use_of_iressa_for_lung_cancer.asp (829 words)

	Chemotherapy & Chemotherapy Drugs: Taxol, Paclitaxel, Xyotax, Iressa & Gefitinib
		Iressa with gefitinib is a new chemotherapy drug designed to inhibit the growth of lung cancer cells by blocking the release of the enzyme tyrosine kinase, which normally aids in their replication.
		Iressa with gefitinib is usually administered as a single chemotherapy drug to treat non-small cell lung cancer that has not effectively responded to other chemotherapy drugs.
		Iressa with gefitinib is successful in decreasing tumor size in roughly 10 percent of patients with non-small cell lung cancer.
	www.lungcancer411.com /html/treatment_chemotherapy.html (769 words)

	Iressa (Getfitinib) drug warnings and precautions - prescription drugs and medications at RxList
		In the event of acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever), IRESSA therapy should be interrupted and a prompt investigation of these symptoms should occur.
		If IRESSA is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy.
		IRESSA is not indicated for use in pediatric patients as safety and effectiveness have not been established.
	www.rxlist.com /cgi/generic3/iressa_wcp.htm (891 words)

	Iressa and Other Targeted Cancer Therapies Forge Ahead
		Iressa is approved as a treatment for patients whose cancer has continued to progress despite treatment with platinum-based and docetaxel.
		Iressa inhibits an enzyme (tyrosine kinase) present in lung cancer cells, as well as in other cancers and normal tissues, that appears to be important to the growth of cancer cells.
		Iressa is being tested on patients to find out how effective it may be to treat common solid tumors, starting with ones that lack effective therapies -- non small cell lung cancer (the commonest type of lung cancer) and head and neck cancer and continuing to breast cancer, colorectal cancer, and hormone-refractory prostate cancer.
	www.psa-rising.com /med/chemo/targeted_iressa102003.htm (3608 words)

	Iressa Information from Drugs.com
		Iressa should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.
		Iressa interferes with the growth of cancer cells and slows their growth and spread in the body.
		Iressa is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby.
	www.drugs.com /iressa.html (1061 words)

	Iressa, FDA Approves Drug for Lung Cancer - Lungs: pulmonary and respiratory health and medical information produced by ...
		Iressa (gefitinib) is a groundbreaking new type of anti-cancer drug for people with the most common type of lung cancer.
		That is, Iressa works by uniquely blocking cellular enzymes that stimulate cell growth.
		Iressa is being approved as a treatment for patients whose cancer has continued to progress despite treatment with platinum-based and docetaxel chemotherapy, two drugs that are currently the standard of care in this disease.
	www.medicinenet.com /guide.asp?s=rss&a=23250&k=Lung_Cancer_Specialty (854 words)

	Iressa and Gefitinib - Chemotherapy Drugs and Side Effects
		Iressa is a pill, taken by mouth, once daily.
		The amount of Iressa that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated.
		Pregnancy category D (Iressa may be hazardous to the fetus.
	www.chemocare.com /bio/iressa.asp (1221 words)

	Iressa news backgrounder: Testing of smart drug expands at M. D. Anderson Cancer Center
		Expanding Iressa's use in head and neck, and thoracic cancers In addition to continuing to test the drug as a treatment for lung cancer, Iressa also will be tested as a possible preventive agent in early stage disease and may further be helpful as maintenance therapy.
		Iressa will soon be studied in treatment of breast cancer in a nationwide clinical trial to be led by Massimo Cristofanilli, M.D., assistant professor in the Department of Breast Medical Oncology.
		Iressa used as a single agent did not prove beneficial in treating breast cancer, but it may work in combination with Armidex by reducing or preventing the development of hormone-resistance, thus increasing the chance of long-term benefit, says Cristofanilli.
	www.eurekalert.org /pub_releases/2004-04/uotm-inb042804.php (2739 words)

	Iressa and ZD1839 research
		Iressa inhibits the tyrosine kinase of epidermal growth factor receptor, which is implicated in cancer cell division, angiogenesis, metastasis and prevention of apoptosis." Wan, Iressa to be investigated as monotherapy for lung cancer after phase III failures" http://www.druginfozone.org/news/Oct02/Oct02_news131.html, Giuseppe Giaccone,
		Iressa and similar drugs target a specific type of cells, and their impact on other normal cells is, at least theoretically, going to be limited.
		Iressa is not available to those who have another cancer (not a metastasis), those with certain other serious health problem (not clearly identified in Astra Zeneca materials).
	www.lungcancerclaims.com /iressaold.htm (10621 words)

	Public Citizen \| Publications - Supplement to Petition to the FDA to Withdraw the Lung Cancer Drug gefitinib (Iressa) ...
		Iressa was approved under an accelerated approval process (Subpart H), which allows approval based on the surrogate endpoint of tumor shrinkage.
		On May 1, 2003, Public Citizen asked that Iressa not be approved[2] because, in addition to the minimal 10% response rate, two large Phase III trials (INTACT 1 and 2) with Iressa as first-line therapy (no treatment prior to Iressa) completed before drug approval were clearly negative with respect to survival.
		Iressa treatment failed to improve either overall survival or progression-free survival in 672 NSCLC patients with Stage III cancer who had previously completed a combined chemotherapy and radiation regimen.
	www.citizen.org /publications/release.cfm?ID=7382&secID=1655&catID=126 (668 words)

	Iressa should have never been approved
		Iressa was approved on July 5th 2002, after only inspection for about 5 months in Japan even though INTACT 1 and 2 had failed the favorable effect of Iressa on overall survival when used as one of the first line agents with other cytotoxic chemotherapeutic agents.
		Iressa was withdrawn, and she was treated with corticosteroids, but died at 21 oﾕclock of the day.
		Iressa was withdrawn because he could not take due to ileus.
	www.npojip.org /iressa/iressaISDB-Feb-2.html (2497 words)

	Alert for Healthcare Professionals: Iressa (gefitinib)
		FDA has approved new labeling for gefitinib (Iressa) that limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from Iressa treatment.
		Iressa, an orally administered epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, was approved for marketing in May 2003 for patients with non-small cell lung cancer (NSCLC) under Subpart H accelerated approval regulations that allow products to be approved on the basis of a surrogate endpoint for clinical efficacy.
		FDA has carefully reviewed data from two failed clinical studies of Iressa, one of which was required by the agency as part of the drug’s accelerated approval.
	www.fda.gov /Cder/drug/InfoSheets/HCP/gefitinibHCP.htm (482 words)

	GNN - Why a Lung Cancer Drug Works So Well for Some People (Site not responding. Last check: 2007-10-27)
		Iressa and drugs such as Gleevac and Tarceva are part of a relatively new class of drugs.
		Tarceva basically targets the same part of the EGFR gene as Iressa, and scientists are eager to compare data from these two studies to the Tarceva trial, including whether a response to one drug can predict a response to the other.
		Iressa came from the lab to the clinic before the mechanism of the drug was truly understood because it so dramatically extended some patients’ lives, which is a positive thing.
	www.genomenewsnetwork.org /articles/2004/04/29/lung_cancer_drug.php (1080 words)

	Imaginis - Researchers Investigate Combination Herceptin/Iressa Treatment for Breast Cancer Patients
		Herceptin and Iressa may be effective in treating some breast cancer cases.
		Iressa is a very new, experimental drug which is thought to block another type of growth factor called EGFR (EGFR is found in moderate amounts in approximately 70% of breast cancer cases).
		Iressa has not yet received FDA approval; its effectiveness is still being evaluated in clinical trials.
	www.imaginis.com /breasthealth/news/news2.28.02.asp (706 words)

	Iressa(TM) gefitinib and Lung Cancer - The Doctors Lounge(TM) (Site not responding. Last check: 2007-10-27)
		FDA has approved new labeling for gefitinib (Iressa) that limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from Iressa treatment.
		The recommended treatment with Iressa (gefitinib) is a 250 mg as one pill each day until lung cancer progression or unacceptable toxicity from the drug.
		Iressa (gefitinib) is the first oral drug approved in the United States for the treatment of non-small cell lung cancer.
	www.thedoctorslounge.net /oncology/articles/iressa_nsclc (904 words)

	GEFITINIB (IRESSA) LUNG CANCER ISEL TRIAL INFORMATION
		AstraZeneca is now actively consulting with Regulatory Authorities to determine the impact of these data and intends to honour a commitment to continue to supply IRESSA to any patient receiving the drug who, in consultation with their physician, wishes to continue treatment.
		Patients currently being prescribed IRESSA should continue to take their medication and should consult their physician about their ongoing treatment at the first opportunity.
		IRESSA is currently licensed for treating the most common form of lung cancer, Non-Small Cell Lung Cancer (NSCLC), which accounts for approximately 80 percent of all lung cancer cases.
	www.astrazeneca.com /pressrelease/4245.aspx (573 words)

	iressa drug information, iressa side effects
		IRESSA for advanced non-small cell lung cancer treatment with an EGFR-TK (epidermal growth factor receptor-tyrosine kinase) inhibitor.
		A year after gefitinib (Iressa) was approved as a last resort for people with advanced non small-cell lung cancer, two studies published today solve the mystery of why the pill is dramatically effective for only about 10% of patients.
		Iressa is used alone to treat lung cancer after other cancer chemotherapy treatments...
	www.drugs.com /drug/iressa (562 words)

	ASTRAZENECA RECEIVES FDA APPROVAL FOR NEW CANCER DRUG IRESSA (gefitinib, ZD1839)
		IRESSA is a once-a-day 250 mg pill and is not typically associated with the severe side-effects often seen with standard cytotoxic chemotherapy treatments used to treat NSCLC patients.
		The total market for drugs used to treat non-small cell lung cancer in the US is estimated to be worth over $1 billion and is set to grow to $4.5 billion in 2011.
		IRESSA was approved for the treatment of inoperable or recurrent NSCLC in Japan in July 2002 and has recorded US $86 million in sales since its launch.
	www.astrazeneca.com /pressrelease/491.aspx (730 words)

	Iressa ( gefinitib ) mesothelioma drug linked to 173 deaths in Japan (Site not responding. Last check: 2007-10-27)
		Update 16 Nov 2002: AstraZeneca emphatically states that not only is Iressa planned to remain on the market, there are no slowdowns expected in the FDA approval process.
		Update 11 Feb 2003: As Japanese physicians were alerted to the possibility that Iressa (Generic name: Gefinitib) was linked to patient deaths, deaths previously not thought to be linked to this drug were reported, causing an increase in the death toll to 173.
		Since Iressa targets a deadly form of cancer in its late stages, even this high death toll (about 0.7%) does not preclude approval; but the label will need to carry strong warnings and the eligible patient population will shrink.
	www.drugintel.com /drugs/iressa.htm (462 words)

	Newly Approved Drug Therapies (828): Iressa (gefitinib), AstraZeneca
		Iressa is an anticancer drug that inhibits an enzyme (tyrosine kinase) present in lung cancer cells, as well as other cancers and normal tissues, that appears to be important to the growth of cancer cells.
		The multicenter clinical trial in the U.S. evaluated the tumor response rate of Iressa 250 and 500 mg/day in 216 subjects with advanced non-small cell lung cancer whose disease had progressed after at least two prior chemotherapy regimens including a platinum drug and docetaxel.
		Iressa was taken once daily at approximately the same time each day.
	www.centerwatch.com /patient/drugs/dru828.html (729 words)

	News - FDA Approves Iressa (Gefitinib), New Treatment For Non-Small-Cell Lung Cancer
		The regulatory package for Iressa fulfilled the FDA's requirements for accelerated approval, created for life threatening conditions where a new drug provides meaningful therapeutic benefit over available therapies, or in the case of Iressa, where no approved treatment exist.
		Iressa is indicated as a monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of both platinum-based and docetaxel chemotherapies.
		The most frequent drug-related adverse events associated with Iressa were diarrhea (48%) sometimes associated with dehydration, rash (43%), acne (25%), dry skin (13%), nausea (13%), and vomiting (12%).
	www.docguide.com /news/content.nsf/news/8525697700573E1885256D1D00660772 (941 words)

	Iressa - Resources from Educational and Academic Institutions (Site not responding. Last check: 2007-10-27)
		Iressa (ZD-1839) and Herceptin are two examples that are now in clinical use.
		Iressa and Tarceva are examples of EGFR blockers; Herceptin was the first HER2 blocker to reach the market.
		Iressa is a once-a-day pill designed to shrink tumors without the harsh side effects of chemotherapy.
	drugs.mongabay.com /Iressa.html (2024 words)

	Gene Mutations Predict Which Lung Cancers Will Respond to Iressa - MGH, April 2004
		Iressa acts by disabling the epidermal growth factor receptor (EGFR) on the surface of lung cancer cells, halting a sequence of signals that can lead to the uncontrolled growth characterizing a malignant tumor.
		Initial analysis found mutations affecting the same area (the ATP cleft of the kinase domain) of the receptor protein in eight of nine patients that had responded to Iressa, but no EGFR mutations were seen in tumors from seven patients who did not respond.
		In addition, many of the patients whose tumors responded to Iressa were of a subtype of NSCLC called bronchoalveolar cancer.
	www.hms.harvard.edu /news/pressreleases/mgh/0404lungcancer.html (854 words)

	Iressa's Trials and Tribulations — Bio-IT World (Site not responding. Last check: 2007-10-27)
		Iressa is a small-molecule tyrosine kinase inhibitor, the same class of drug as Novartis' Gleevec.
		Herceptin and Gleevec are rationally designed cancer drugs, but unlike Iressa, the most responsive patients taking these drugs were identified prior to trials based on unequivocal expression of protein or genetic markers.
		Without that benefit, it is possible that the Iressa trials thus far have been underpowered to reveal a significant Phase III benefit.
	www.bio-itworld.com /archive/101003/firstbase.html (1187 words)

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