Navigation Links
FDA approves Novartis drug Gleevec® label recommending extending treatment to three years for certain GIST patients after surgery
Date:2/1/2012

s to recommend consideration of at least three years of adjuvant therapy with Gleevec for patients with high-risk GIST(2).

In addition to extending the Gleevec label to three-year treatment duration in patients with KIT+ GIST after surgery, the FDA has agreed that all accelerated post-approval commitments for this indication have been met, confirming the clinical benefit of adjuvant treatment with Gleevec.

Study details
The SSG XVIII clinical trial was conducted by the Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO). This trial was a multicenter, prospective, randomized study for the evaluation of adjuvant treatment with Gleevec of histologically confirmed KIT+ GIST(5).

The primary endpoint of the study was to compare, within the first five years, recurrence-free survival in patients with a greater than 50% estimated risk of GIST disease recurrence, following diagnosis and treatment with adjuvant Gleevec for either 12 or 36 months. The secondary endpoints included overall survival and treatment safety(1).

Three hundred ninety-seven patients entered the study. Inclusion criteria for risk of recurrence was defined as tumor diameter >5.0 cm and mitotic count >5/50 high power fields (HPFs); or tumor diameter >10.0 cm, any mitotic count; or tumor of any size with a mitotic count >10/50 HPFs; or tumors ruptured into the peritoneal cavity.

Recurrence-free survival was longer in the 36-month group compared to the 12-month group (HR 0.46, 95% CI 0.32-0.65; p<0.0001). Patients assigned to 36 months of Gleevec after surgery had longer overall survival (HR 0.45, 95% CI 0.22-0.89; p=0.0187). Almost all patients experienced side effects while taking Gleevec. Gleevec was generally well tolerated. The proportion of patients who discontinued Gleevec during the assigned treatment period for reasons other than GIST recurrence was 26% over the full three yea
'/>"/>

SOURCE Novartis
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... , August 22, 2014 ... Hospital TVs Today Lincor announced general availability ... Engagement solution that delivers a range of education, entertainment ...      (Logo: http://photos.prnewswire.com/prnh/20140822/702945) , ... defining point of care patient engagement to bedside smart ...
(Date:8/22/2014)... -- WaferGen Bio-systems, Inc. (NASDAQ: WGBS) today announced the pricing ... stock and warrants at a price of $10,000 per ... deducting underwriting discounts and commissions and offering expenses payable ... separable and will be issued separately.  The shares of ... NASDAQ Stock Market under the ticker symbol "WGBS" on ...
(Date:8/21/2014)... , Aug. 21, 2014 Nektar ... International Inc. today announced positive results from its ... an investigational, extended half-life recombinant factor VIII (rFVIII) ... Factor (Recombinant)], which met its primary endpoint in ... arm compared to the on-demand arm. ...
Breaking Medicine Technology:Lincor Unveils Next Generation TV-based Patient Engagement Solution 2WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 2WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 3WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 4Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 2Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 3Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 4Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 5
... New Jersey, May 31, 2012 The Dueling Pianos ... th . The event is slated 6.30 pm onwards and promises ... Pianos, based out of the Philly area since March of 1990, ... the east coast, from Boston to North Carolina, out to Anaheim, ...
...  Just days after the Senate overwhelming approved legislation to better ... followed suit, passing the Food and Drug Administration Reform ... The Bulk Pharmaceuticals Task Force (BPTF), an affiliate ... (SOCMA), welcomed the vote and urged House and Senate conferees ...
Cached Medicine Technology:SIRO Clinpharm Announces a Fabulous Date With the Dueling Pianos 2SOCMA's Bulk Pharmaceuticals Task Force Welcomes House Passage of FDA Reform Act 2
(Date:8/22/2014)... to open blockages in the kidney arteries may ... modern clinical trials, according to new recommendations for ... Cardiovascular Interventions today by the Society for ... Case Medical Center,s Sahil Parikh, MD, Director, Interventional ... Western Reserve University School of Medicine was the ...
(Date:8/22/2014)... 2014 Menstrual leaks risk stains and ... Fla., decided that there needed to be a better ... and producible in design variations, the Safety Net optimizes ... which avoids embarrassment and promotes peace of mind. The ... , The original design was submitted to the Fort ...
(Date:8/22/2014)... FRIDAY, Aug. 22, 2014 (HealthDay News) -- People who ... for the lower levels of nicotine, according to a ... toxic chemicals than other smokers, the researchers say. ... to 65, who smoked regular cigarettes with nicotine emission ... The participants then switched to reduced-nicotine cigarettes for the ...
(Date:8/22/2014)... News) -- Many children get anxious or afraid when ... a number of ways that parents can make these ... The first step is to explain to children in ... health, said Rita John, director of the pediatric primary ... Nursing in New York City. "Children need to ...
(Date:8/22/2014)... FRIDAY, Aug. 22, 2014 (HealthDay News) -- College can be ... number of things they can do to make the most ... "a time to adjust, explore, meet new people and learn ... director of student wellness and assessment at St. John,s University ... "Not all learning takes place in the classroom. College ...
Breaking Medicine News(10 mins):Health News:UH Case Medical Center's Dr. Parikh authors SCAI paper on renal artery stenosis treatment 2Health News:UH Case Medical Center's Dr. Parikh authors SCAI paper on renal artery stenosis treatment 3Health News:Low-Nicotine Cigarettes May Not Lead to More Smoking 2Health News:Simple Steps Make Shots Less Scary for Kids, Nurse Says 2Health News:College Prep 101 2
... -- Eating a diet high in trans fatty acids, an ... meals and snacks, might be associated with negative -- and ... the study, researchers from the University of California, San Diego ... men and women. They also considered other possible contributing factors, ...
... Patients with early stage malignant pleural mesothelioma (MPM), ... lungs, may be eligible for aggressive multi-modality therapy involving ... and controversy has existed about which approach is superior. ... surgery where surgeons remove the entire diseased lung, lung ...
... pounding to the beat in group exercise class has become the ... of changing in the locker room, the acts of disrobing, dressing, ... discomfiting. It,s a complex experience as women are faced with an ... "I walk into the change room and pace anxiously up and ...
... with lower risk of heart disease, but data for ... total of 83,578 female participants of the Nurses, Health ... cancer at baseline were followed-up from 1980 to 2006. ... and updated approximately every 4 years, whereas stroke and ...
... is a clear relationship between androgenetic alopecia (common premature ... of the prostate that appears in aging men and ... appears in 50% of men over 60 year old ... the light of the study published in the ...
... study published today in the Journal of Clinical ... children and adolescents with acute lymphoblastic leukemia (ALL), the ... those diagnosed during the years 1990-1994, to 90.4 percent ... improved survival is due to using existing drugs better, ...
Cached Medicine News:Health News:Could Trans Fats Make You Cranky? 2Health News:Pleurectomy/decortication proposed preferred surgical procedure 2Health News:The stress of undress 2Health News:The stress of undress 3Health News:Moderate drinking associated with lower risk of stroke in women 2Health News:A study confirms the correlation between premature alopecia and prostate conditions 2Health News:Largest ever study of childhood ALL shows improving survival 2
... WatchMate system is designed to protect a ... and becoming lost or injured. Such residents ... etc., or have suffered a head injury., ... on their wrist or ankle, and points ...
... Smart™ Labels have a direct thermal ... Instruments Tag-it™ HF-I transponder. When processed ... text and other graphics may be ... data is programmed to the RFID ...
... a patent pending solution using Radio ... a smart label to promote patient ... wrong-site, wrong-procedure surgery. This simple to ... orthopedic surgeon with the operating room ...
... Hospitals, correctional facilities, recreational venues ... wristbands to provide automated data capture ... reducing costly and dangerous errors. RFID ... admissions wristbands at entertainment venues as ...
Medicine Products: