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:3/3/2015)... KUALA LUMPUR, Malaysia , March 3, 2015 ... in the pharmaceutical market. It not only provides ... convenience of handling, and proper delivery. As patent ... need for packaging will steadily rise, in turn ... for customization is further expected to drive the ...
(Date:3/3/2015)... 2015 Medical Tracking Solutions, Inc., developers ... of Brian Timberlake as Senior Vice ... and build relationships with existing and new clients. Brian ... sales, and sales management as well as a ... a comprehensive inventory management system that provides real-time ...
(Date:3/3/2015)... March 3, 2015  Cumberland Pharmaceuticals Inc. (NASDAQ: ... on hospital acute care and gastroenterology, today announced ... Company,s revenue grew 15% in 2014 to $37 ... or $0.35 per diluted share. At the end ... $95 million including $55 million in cash and ...
Breaking Medicine Technology:Customization is the New Formula in Global Pharmaceutical Packaging, Finds Frost & Sullivan 2Customization is the New Formula in Global Pharmaceutical Packaging, Finds Frost & Sullivan 3Customization is the New Formula in Global Pharmaceutical Packaging, Finds Frost & Sullivan 4Medical Tracking Solutions, Inc. Hires New SVP, Sales 2Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 2Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 3Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 4Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 5Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 6Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 7Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 8Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 9Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 10Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 11Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 12Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 13Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 14Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 15Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 16Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 17Cumberland Pharmaceuticals Announces Return To Growth And Profitability In 2014 18
... April 18, 2012   A new retrospective sub-analysis ... of intracranial hemorrhage (ICH), including both fatal and traumatic ... twice daily compared with warfarin. Results of the sub-analysis ... of the American Heart Association. Intracranial ...
... Although adherence to hypertension medications was significantly associated ... are higher for adherent patients than for patients who ... pharmacy benefit manager Prime Therapeutics (Prime) that will be ... Pharmacy (AMCP),s 24th Annual Meeting & Expo in San ...
Cached Medicine Technology:New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 2New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 3New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 4New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 5New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 6New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial 7Hypertension Drug Adherence Associated with Fewer Hospitalizations and Lower Medical Costs but Increased Total Care Costs 2
(Date:3/4/2015)... Information Innovators Inc . (Triple-i) is honored ... the company as Chief Technology Officer. Mr. Dvorak will ... company, including customer-centric strategies and initiatives, and promoting continuous ... as a technology executive and visionary. Prior to joining ... including oversight of enterprise data management, analytic software development, ...
(Date:3/4/2015)... 04, 2015 In a small ceremony with ... on their new facility in New Port Richey on February ... new facility will allow the Florida drug detox facility ... drug abuse epidemic through treatment and education. “Due to our ... in the United States, we made the decision that expanding ...
(Date:3/4/2015)... 2015 i2i Systems Population Health ... Chase Brexton Health Care, a 35-year-old Maryland-based community ... Brexton provides comprehensive primary care, behavioral health and ... seven clinics in the greater Baltimore area of ... records, the organization has always focused on providing ...
(Date:3/4/2015)... March 04, 2015 Dietary supplement company ... the world’s first biocompatible copper chelate, at Natural Products ... guests the chance to gain insight into their wellness ... the Cunermuspir complex can support their individual nutritional needs, ... which is the core ingredient of the MitoSynergy product ...
(Date:3/4/2015)... 2015 The report “Vasculitis – Pipeline ... development for Vasculitis. Vasculitis is a disease that features ... vasculitis diseases is not known. Vasculitis can affect any ... symptoms. Symptoms can include fever, weight loss, tiredness, aches, ... in a limb. Vasculitis is treatable, but it is ...
Breaking Medicine News(10 mins):Health News:Information Innovators Inc. Announces Mr. John Dvorak as the New Chief Technology Officer 2Health News:Information Innovators Inc. Announces Mr. John Dvorak as the New Chief Technology Officer 3Health News:Novus Medical Detox Hosts Ribbon Cutting Ceremony at Pasco County Facility 2Health News:Novus Medical Detox Hosts Ribbon Cutting Ceremony at Pasco County Facility 3Health News:Chase Brexton Selects i2i Systems Population Health Management Solutions to Demonstrate HEDIS Quality Outcomes to Maryland’s Health Plans 2Health News:Chase Brexton Selects i2i Systems Population Health Management Solutions to Demonstrate HEDIS Quality Outcomes to Maryland’s Health Plans 3Health News:MitoSynergy Invites Expo West Attendees to Sit Back, Relax and Take Time for Their Health 2Health News:Vasculitis Therapeutics Pipeline H1 2015 Review Report Available at RnRMarketResearch.com 2Health News:Vasculitis Therapeutics Pipeline H1 2015 Review Report Available at RnRMarketResearch.com 3Health News:Vasculitis Therapeutics Pipeline H1 2015 Review Report Available at RnRMarketResearch.com 4
... Chicago offers information on prevention and treatment of knee injuries. ... offers tips for reducing risks, including knee-specific strengthening exercises. , ... ... that more than 1.4 million women tear an Anterior Cruciate Ligament ...
... researchers say , , FRIDAY, July 18 (HealthDay News) -- ... of functioning heart blood vessels that cardiac surgeons create ... replace some heart surgery with injections of laboratory-grown cells ... system of blood vessels for damaged hearts that need ...
... Mexican Cuisine are Featured at East LA Meets Napa ... Benefiting AltaMed Health Services Corporation, LOS ANGELES, July ... LA Meets Napa celebration featuring more than 20 Latino,owned/managed ... Mexican,restaurants. The event was attended by more than 1,000 ...
... MONICA, Calif., July 18 Two consumer,groups today ... controversial patent,on human embryonic stem cells held by ... formerly The Foundation for Taxpayer and Consumer,Rights, and ... Patent,Office,s Board of Appeals and Interferences. The PTO ...
... hour before they undergo spinal surgery greatly reduces the ... Johns Hopkins study to be published in the August ... available online ahead of print). Children who received antibiotics ... half times more likely to develop serious infections at ...
... vaccine fails to ease symptoms, but old drug offers new ... one step forward, one step back in the search for ... in the July 19 issue of The Lancet , ... in a second report, a once-promising vaccine failed to prevent ...
Cached Medicine News:Health News:Complimentary Sports Injury Prevention Pamphlet for Women Offered by NOHC of Chicago 2Health News:Complimentary Sports Injury Prevention Pamphlet for Women Offered by NOHC of Chicago 3Health News:Heart Blood Vessels Grown in the Lab 2Health News:Move Over Margarita! Mexican Food has a New Dinner Partner 2Health News:Move Over Margarita! Mexican Food has a New Dinner Partner 3Health News:Consumer Groups File Appeal on Challenge of Human Stem Cell Patent Held By WARF 2Health News:Averting postsurgical infections in kids: Give antibiotics within hour before first incision 2Health News:Alzheimer's Research Brings Progress, Setbacks 2Health News:Alzheimer's Research Brings Progress, Setbacks 3Health News:Alzheimer's Research Brings Progress, Setbacks 4
Providing a perfect combination of capacity, speed and innovation, the Concept 400 delivers simple sophistication and new levels of comfort and convenience....
Lose the variability of anaerobic jars and step into the 21st century with the anaerobic workstation that provides the answer to the common problems associated with anaerobic microbiology....
... MARS Enduro is the ideal partner ... required before, during or directly after ... longitudinal adjustment and the filigreed construction, ... in examination, induction and operating theatre. ...
23" Top Slide with Full Table Functions for Every Procedure...
Medicine Products: