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FDA information on TarcevaArticle Summary: FDA approved Tarceva for treatment of locally advanced or metastatic non-small cell lung cancer, after [url=http://www.tnnoa.com/parajumpers.php]Parajumpers Doudoune[/url] failure of at least one prior chemotherapy regime in November 2004. OSI, the manufacturers of the drug had anticipated late January as the deadline for the approval, however FDA's approval came well before in time, making it one of the fastest approvals ever. It approved Tarceva in their 'Pilot Program for Continuous Marketing Applications.'
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FDA approved Tarceva for treatment of locally advanced or metastatic non-small cell lung cancer, after failure of at least one prior chemotherapy regime in November 2004. OSI, the manufacturers of the drug had anticipated late January as the deadline for the approval, however FDA's approval came well before in time, making [url=http://www.mifss.it/moncler-outlet-italia-il/]moncler outlet italia[/url] it one of the fastest approvals ever. It [url=http://www.rehearsaltheapp.com/comment-page-3#comment-252703]RecommendedOnline Network Marketing Tips For Beginners[/url] approved Tarceva in their "Pilot Program for Continuous Marketing Applications." This pilot program was started keeping Tarceva like drugs in mind which demonstrated significant promise as a therapeutic advance over the conventional chemotherapy during the clinical trials, and hence given a Fast Track status.
A randomized double- blind, placebo- controlled pivotal Phase III trial of NSCLC patients with second and third line advance was carried out. The trial comprised of 731 advance-staged NSCLC patients who had undergone one or more chemotherapy regimes, which had failed to produce the desirable results. The conclusions were:
The comparison between Tarceva, placebo and Iressa during this trial concluded that while Tarceva prolonged the NSCLC patient's life by 6.7months placebo did the same for 4.7 months and Iressa just shrink the tumors with no increase [url=http://www.matevert.fr/category/doudoune-moncler-france/]doudoune moncler france[/url] in the life span. Other than this, 31.2% of patients taking Tarceva were alive after one year, versus 21.5% in the placebo arm.
Tarceva also met its second [url=http://www.cdtempo.fr/abercrombie-paris/]abercrombie paris[/url] milestone of the trial by
delaying the time of symptom deterioration,
improving progression free survival
Increasing tumor response rate.
Post this Phase III trial of NSCLC patients with second and third line advance, FDA approved Tarceva to be used in combination with gemcitabine chemotherapy as a cure for locally advanced, inoperable or metastatic pancreatic cancer patients, who have not been administered any chemotherapy, in November 2005. Once again a randomized double- blind, placebo- controlled Phase III [url=http://www.leherodeslapins.fr/hollister/]hollister[/url] clinical study of Tarceva, in combination with gemcitabine chemotherapy was performed on 569 patients with unresectable locally advanced or metastatic pancreatic cancer. The conclusions were:
Primary Milestone of improving overall survival rate by 23% was met.
Patients receiving Tarceva in combination with gemcitabine chemotherapy were alive by 21% as compared to 19% patients receiving a combination of placebo with gemcitabine chemotherapy
Hazard ratio=0.76 implied a significant improvement in progression free survival.
In April 2010, FDA approved Tarceva to be administered as a maintenance drug to NSCLC patients, whose cancer has not spread or grown after the initial treatment of chemotherapy. However, it was to be noted that NSCLC patients should not have used Tarceva along with certain types of chemotherapy.
Tarceva, not only had a lot of benefits over the other targeted drug, it also had fewer side effects than the conventional chemotherapy. Skin rashes and diarrhea were the most common side effects associated with this medicine. Rare and hardly reported but there had been cases of lung cancer, bleeding or clotting problems, thinning of stomach and intestine linings, kidney or liver related problems, heart attacks or strokes when Tarceva was used [url=http://www.sandvikfw.net/shopuk.php]hollister outlet sale[/url] in combination with other drugs.Non- Small Cell Lung Cancer (NSCLC) [url=http://www.cdtempo.fr/abercrombie-pas-cheres/]abercrombie pas cher[/url] patients whose cancer has not spread or grown after initial treatment with certain chemotherapies can be prescribed Tarceva, as a maintenance drug. However, there have been reports on possible effects on:
Lungs
Kidneys and liver
Stomach and intestines
Skin and
Eyes
Minor Side Effects:
Mild-to-moderate rash, diarrhea, and changes in the skin were the most [url=http://www.viarosmini33.it]Woorich Outlet[/url] common side effects associated with the use of this medicine.
Rashes-
Generally occur within 8 days from the commencement of the treatment; however, there have been cases, where they [url=http://rio-grande.siggraph.org/2011/12/09/bar-camp-2012/#comment-794043]Online Poker Betting Structure - written by J Finney[/url] have erupted later.
Typically appear on the upper body or face
The rashes are not allergic reactions and may appear as acne or dry skin. However, these rashes should not be mistaken for acne as well, and the practitioner should be consulted at once, upon the eruption of [url=http://www.viarosmini33.it/woolrich-bologna-outlet-online/]woolrich bologna outlet online[/url] rashes.
Diarrhea-
Can occur within 12 days of starting Tarceva
Hair and Nail changes have also been noticed with the use of this drug.
Major Side Effects:
Seek immediate medical attention, if following signs or symptoms appear:
Skin rash which are new or worsening
Continual diarrhea, nausea, loss of appetite, or vomiting
Shortness of breath [url=http://www.stratigo.de]Hollister Deutschland[/url] or cough
Eye irritation
Other than the above mentioned discomforts, Tarceva is also known to cause:
Effects on Lungs- though rare but this drug has reported to cause interstitial lung disease- like events, which is a serious disorder of lungs.
Effects on [url=http://www.cdtempo.fr/abercrombie-pantalons/]abercrombie pantalons[/url] Kidneys and Liver- some patients have also complained of kidney or liver related issues. So in case one is suffering from any kind of kidney or liver related ailments, then the same should be discussed with the doctor before starting Tarceva.
Effects on Stomach and Intestines- people who are suffering from stomach or intestine related health issues, or patients taking Tarceva in combination with other drugs have at times, developed hole in the linings of these two organs. In such cases, though rare, but death has [url=http://www.aparteprato.it/category/sito-ufficiale-moncler/]sito ufficiale moncler[/url] also been reported.
Effects on Skin- Tarceva has caused serious skin conditions which have even led to deaths. As mentioned earlier, rashes are common side effects of this drug, which can be mistaken for acne. Such kind of rashes should not be ignored, and discussed with the doctor at once. As a first aid, the affected area should be cleaned by a moist soap, followed by moisturizing the same. Exposure to sun should be avoided, and before moving out, a sunscreen with SPF 15 or more should be [url=http://www.leherodeslapins.fr/hollister-paris-soldes-2/]Hollister Paris Soldes[/url] applied along with [url=http://www.translatica.co.uk/hollister-outlet.html]hollister outlet[/url] a hat. Over-the-counter acne treatments should be avoided [url=http://www.matevert.fr/category/doudoune-moncler-solde/]doudoune moncler solde[/url] and the make-up should be removed with gentle liquid cleansers.
Effects on Veins and Heart- Patients using [url=http://wordpress.digitalnature.ro/mystique#comment-704873]Tying Fly Fishing Flies - The Frankenstein Fly - written by Nomad Rick[/url] a combination of Tarceva and gemcitabine were at a higher risk of suffering from bleeding or clotting problems such as heart attacks or strokes.
Effects on Eyes- Eye irritation and damage to cornea have also been associated with Tarceva. Abnormal eyelash growth, dry eyes, or variation in eyesight are the other problems reported due to Tarceva administration.
Any discomfort after starting this medicine should be discussed with the doctor immediately, before it gets worse and causes serious complications.
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