Navigation Links
FDA Approves Gleevec For Expanded Use in Patients With Rare Gastrointestinal Cancer
Date:1/31/2012

SILVER SPRING, Md., Jan. 31, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today's action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Gleevec was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002. In 2008 Gleevec received a subsequent accelerated approval for adjuvant use that is for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST tumors, but who were at increased risk for a recurrence. The accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted. Regular approval for the metastatic GIST indication was also granted in 2008.

GIST is a rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which regulates body processes such as food digestion. More than half of GISTs start in the stomach.

"The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of Gleevec can prolong patient's lives in earlier disease settings."

The label is being updated to include clinical data from a large randomize
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
2. ASAM Approves Prescription Drug Policy
3. FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
4. FDA Approves Shared REMS (Risk Evaluation and Mitigation Strategy) Program for all TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments
5. FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
6. FDA Approves Mechanical Cardiac Assist Device for Children With Heart Failure
7. FDA Approves Hologics Cervista High Throughput Automation System for Cervical Cancer Screening
8. FDA Approves First Generic Version of Cholesterol-Lowering Drug Lipitor
9. FDA Approves First Insomnia Drug for Middle-of-the-Night Waking Followed By Difficulty Returning to Sleep
10. FDA Approves Eylea for Eye Disorder in Older People
11. FDA Approves First Supplemental Test for Chagas Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Jan. 23, 2015  HyGreen, Inc., a leader in hand ... with RCA Medical, a subsidiary of Ascendis Health Limited, ... Each year, hundreds of millions of patients around ... organisms are transmitted from patient to patient via the ...
(Date:1/23/2015)... N.Y. , Jan. 23, 2015  Lixte Biotechnology Holdings, Inc. ... its Phase I trial of Lixte,s lead compound, LB‑100, is ... John S. Kovach , M.D., the founder ... planned to be completed at a single site. Accrual of ...
(Date:1/23/2015)... Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: CTSO), ... extracorporeal cytokine adsorber to reduce deadly inflammation in ... of $385,642, net of transaction costs, in non-dilutive ... Business Tax Certificate Transfer Program sponsored by the ...
Breaking Medicine Technology:HyGreen Partners with RCA Medical in Johannesburg, South Africa 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3
(Date:1/22/2015)... Plainsboro, NJ (PRWEB) January 22, 2015 ... advocate and keynote speaker at the upcoming 32nd ... by ACCME-accredited Physicians’ Education Resource®, LLC (PER®) , ... breast would have gone undetected if she had not ...
(Date:1/22/2015)... 22, 2015 Yesterday, Senator Holly ... and Kristin Olsen (R-Modesto) were honored by the ... advancing biotechnology, biomedical science, medical device and pharmaceutical ... received the “2014 Life Sciences Champion” award from ...
(Date:1/22/2015)... January 22, 2015 IsoComforter, Inc. has introduced ... with patented IsoTube design to treat specific body parts and ... most progressive and easy to use patented cold therapy machine ... sports related orthopedic and muscle injuries. IsoComforter has become ...
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... NY (PRWEB) January 22, 2015 As interest ... overall health care gains momentum worldwide, Rev. Eric J. ... HealthCare Chaplaincy Network (HCCN), will be the keynote speaker ... care in Israel’s public health system. , The conference, “Hope ...
Breaking Medicine News(10 mins):Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3
... Reporter , TUESDAY, July 13 (HealthDay News) -- During ... members of the U.S. government panel that could decide the ... A decision on whether to ban Avandia or not ... that the drug,s maker, GlaxoSmithKline, may have buried or manipulated ...
... The decision regarding treatment following breast-conserving surgery for patients ... an area of discussion and confusion for patients and ... low, the risk of local recurrence in the breast ... and hormone treatment. While both treatments have been ...
... July 15, 2010 An immune-system protein already used to ... of cancers might also aid asthma patients, UT Southwestern Medical ... the protein interferon blocks the development of a population of ... of a class of T lymphocytes, called T helper 2 ...
... of Mississippi Medical Center and four collaborating academic medical ... of Health to identify risk factors for Alzheimer,s disease ... Mosley, UMMC professor of geriatric medicine and one of ... will pay for the ARIC Neurocognitive Study, a comprehensive ...
... Reporter , TUESDAY, July 13 (HealthDay News) -- Patients ... symptoms frequently attributed to memory problems or difficulty finding ... brain disorder may also have a reduced ability to ... from the University of Florida and other institutions showed ...
... Tolstoy portrayed Russians as a brooding, complicated people, and ... dark feelings and memories more than Westerners do. But ... though Russians tend to brood, they are less likely ... "Among Westerners, focusing on one,s negative feelings tends ...
Cached Medicine News:Health News:FDA Panel Seems Skeptical Over Key Avandia Data 2Health News:FDA Panel Seems Skeptical Over Key Avandia Data 3Health News:FDA Panel Seems Skeptical Over Key Avandia Data 4Health News:Prediction tool helps estimate local recurrence in patients with noninvasive breast cancer 2Health News:Prediction tool helps estimate local recurrence in patients with noninvasive breast cancer 3Health News:Interferon might help asthma patients breathe easier, UT Southwestern study suggests 2Health News:University of Mississippi Medical Center to lead in nationwide NIH-funded Alzheimer's study 2Health News:University of Mississippi Medical Center to lead in nationwide NIH-funded Alzheimer's study 3Health News:Emotions May Be Blunted in Alzheimer's Patients 2Health News:Emotions May Be Blunted in Alzheimer's Patients 3Health News:Brooding Russians: Less distressed than Americans 2
To maintain the conjunctival cul-de-sacs after enucleation or evisceration without hindering lid closure....
To maintain the conjunctival cul-de-sacs after enucleation or evisceration without hindering lid closure....
... plugs are coated with a ... that makes the surface slick ... and to prevent debris from ... partial occlusion. For partial stenosis. ...
With side bite Instrument recommended to catch the polypropylene thread in the nose....
Medicine Products: