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

EAST HANOVER, N.J., Feb. 1, 2012 /PRNewswire/ -- Novartis announced today that following a priority review, the US Food and Drug Administration (FDA) has approved an update to the Gleevec® (imatinib mesylate)[*] tablets label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen has been shown to improve recurrence-free survival (RFS) and overall survival (OS) for KIT+ GIST patients compared to 12 months of treatment(3).

The US approval was based on data from an international, multicenter, open-label, Phase III clinical trial. Results of the study showed that 36 months of Gleevec treatment significantly prolonged RFS compared to 12 months of Gleevec treatment, which was a 54% reduction in the risk of recurrence (p<0.0001). In addition, 36 months of Gleevec treatment resulted in a 55% reduction in the risk of death compared to one year of treatment (p=0.0187). The median time of follow-up was 42 months for RFS and 48 months for OS(3).

"This approval represents another important step in the progress of KIT+ GIST treatment that began a decade ago when Gleevec was first approved to treat metastatic KIT+ GIST," said Herve Hoppenot, President, Novartis Oncology. "With the significant survival benefit resulting from three years of adjuvant treatment, GIST patients now have a more effective regimen to help manage their disease."

Gastrointestinal stromal tumors are a rare, life-threatening cancer of the gastrointestinal tract. The major cause of GIST is an abnormal form of the protein KIT which causes cells to grow uncontrollably and become cancerous(4). Patients with GIST are at risk of recurrence following complete resection of primary GIST(2).

In August 2011, the US National Comprehensive Cancer Network (NCCN) updated its clinical practice guideline
'/>"/>

SOURCE Novartis
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

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:5/17/2013)... , May 17, 2013  Sorrento Therapeutics, Inc. ... Fast-Track Advanced Technology Small Business Technology Transfer Research ... Allergy and Infectious Diseases (NIAID), a division of ... development of novel human antibody therapeutics to combat ... or Staph) infections, including methicillin-resistant S. aureus ...
(Date:5/17/2013)... SAN DIEGO and CAMBRIDGE, Mass., May 17, 2013 ... announce that a purchaser of Aveo Pharmaceutical, Inc. (NASDAQGS: ... District Court for the District of Massachusetts ... of its officers violated the Securities Exchange Act of ... May 1, 2013 (the "Class Period"). (Logo: ...
(Date:5/17/2013)... 2013 /PRNewswire-iReach/ -- United Medical Education, a company that ... Pediatric Advanced Life Support (PALS) and Basic Life Support ... ACLS online course manuals. In order to gain ... build an account with the company. By offering the ... Medical Education is setting a precedent among similar companies. ...
Breaking Medicine Technology:Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 2Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 3Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 4Aveo Pharmaceuticals, Inc. Sued by Investor 2Aveo Pharmaceuticals, Inc. Sued by Investor 3ACLS Online Course Manuals are Now Available at No Cost through United Medical Education 2
... WIRE)--Apr 13, 2007 - Ascenta Therapeutics,Inc. announced today ... be featured in three oral,presentations and several poster ... American Association for Cancer Research,(AACR), to be held ... MDM2 program has been selected for presentation at ...
... /PRNewswire-FirstCall/ - AEterna,Zentaris Inc. , a global, pure ... today announced that it,will present two abstracts outlining ... well as in vivo data on its GHRH ... for the treatment of cancer. These abstracts will ...
Cached Medicine Technology:Ascenta Therapeutics Highlights Multiple Data Presentations at,Upcoming AACR Annual Meeting 2Ascenta Therapeutics Highlights Multiple Data Presentations at,Upcoming AACR Annual Meeting 3Ascenta Therapeutics Highlights Multiple Data Presentations at,Upcoming AACR Annual Meeting 4Ascenta Therapeutics Highlights Multiple Data Presentations at,Upcoming AACR Annual Meeting 5Ascenta Therapeutics Highlights Multiple Data Presentations at,Upcoming AACR Annual Meeting 6AEterna Zentaris To Present First In Vitro Data for PI3K Inhibitors,and In Vivo Results for a GHRH Antagonist at the AACR Annual,Meeting in Los Angeles 2AEterna Zentaris To Present First In Vitro Data for PI3K Inhibitors,and In Vivo Results for a GHRH Antagonist at the AACR Annual,Meeting in Los Angeles 3
(Date:5/19/2013)... (PRWEB) May 19, 2013 According to a ... Firmers” many people are self-conscious about the appearance of certain ... option when diet and exercise fail to tone and tighten ... appeal to those looking to get the firmest body ... an effective mini-overview,” says Dr. Simon Ourian, Medical Director of ...
(Date:5/19/2013)... People in Minnesota have a great option to ... its 28 Day Fat Loss Formula. The best part ... their own home. The product sells for $135 dollars and ... accessed here: http://altmanfitness.com/28-day-fat-loss-formula/ , “Bikini season is almost ... but after using the 28 Day Fat Loss Formula they ...
(Date:5/19/2013)... May 19, 2013 The muscles in ... their functionality and one of the biggest and most ... nervous system. The peripheral system comprises of peripheral nerves ... cord. These nerves ensure that the limbs and hands, ... when these nerves get damaged due to trauma or ...
(Date:5/19/2013)... According to a new market ... (2013 – 2018): By Applications (Healthcare (Endoscopy, Radiology, ... CMOS, Contact IS, Infrared, X-Ray) And Geography" published ... was $8.00 billion in 2012 and is expected ... estimated CAGR of 3.84% from 2013 to 2018. ...
(Date:5/19/2013)... (PRWEB) May 19, 2013 The report ... Global Trends & Forecasts up to 2017” published by ... market with analysis and forecasting of the global volume ... identifies the driving and restraining factors for the global ... imperatives, and challenges. The market is segmented and revenue ...
Breaking Medicine News(10 mins):Health News:Body Firming – The Hottest Treatments Available 2Health News:Ultimate Neuropathy Support System Launched by Neuracel - Reaching New Heights in Herbal Medication for Peripheral Neuropathy 2Health News:Image Sensors Market to Reach $10.75 Billion by 2018 at a CAGR of 3.84% - New Report by MarketandMarkets 2Health News:Image Sensors Market to Reach $10.75 Billion by 2018 at a CAGR of 3.84% - New Report by MarketandMarkets 3Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 2Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 3
... Structured as a Social Business Enterprise, Facility Can ... Cataract Operations Annually, DHAKA, Bangladesh, May 2 ... to perform 50,000 eye examinations and,10,000 cataract operations ... laureate Professor Muhammad Yunus and the Hon,ble Adviser, ...
... New York, NYHealth insurance coverage and unpaid health care ... coverage costs the U.S. public $45 billion a year, ... today. This includes $33 billion in the cost of ... Health Insurance Program, and $12 billion in uncompensated care ...
... Approval Ratings Consistent with Public,s Support of ,Medicare for ... All, or Single-payer Healthcare, ... enact healthcare reform surfacing in Sacramento, a new field poll,this week ... of the California Nurses Association and registered,nurses., A poll this ...
... -- Beginning this Mother,s,Day, women across America will ... shows that when women take care of themselves, ... of this nationwide,initiative and to celebrate the launch ... the five minute daily solution for your smile ...
... PET Registry (NOPR) Study Showcases the Need to,Expand ... Cancer Treatment, WASHINGTON, May 1 US ... treatment and research networks,representing approximately 1,200 oncologists nationwide, ... Clinical Oncology (JCO) that,demonstrates the value of positron ...
... is available in French . , , ... Health Centre (MUHC) have performed the worlds first ... the new system developed by the researchers administers ... effects completely automatically, with no manual intervention. , ...
Cached Medicine News:Health News:Professor Muhammad Yunus and The Green Children to Open First Grameen Eye Hospital in Bangladesh on May 12, 2008 2Health News:Professor Muhammad Yunus and The Green Children to Open First Grameen Eye Hospital in Bangladesh on May 12, 2008 3Health News:$45 billion a year is spent by public on health costs for full-time workers and families 2Health News:$45 billion a year is spent by public on health costs for full-time workers and families 3Health News:$45 billion a year is spent by public on health costs for full-time workers and families 4Health News:Field Poll: California Nurses Association Most Favorably Viewed Group in Healthcare Arena 2Health News:Field Poll: California Nurses Association Most Favorably Viewed Group in Healthcare Arena 3Health News:Protect Yourself From Teeth to Toes! Lindsay Price and Crest Whitestrips Daily Whitening + Tartar Protection Partner to Empower Women for the 9th Annual National Women's Health Week 2Health News:Protect Yourself From Teeth to Toes! Lindsay Price and Crest Whitestrips Daily Whitening + Tartar Protection Partner to Empower Women for the 9th Annual National Women's Health Week 3Health News:US Oncology Applauds Journal of Clinical Oncology Study Highlighting Value of PET Scans for Cancer Patients With Various Types of Malignancies 2Health News:US Oncology Applauds Journal of Clinical Oncology Study Highlighting Value of PET Scans for Cancer Patients With Various Types of Malignancies 3Health News:World first: researchers develop completely automated anesthesia system 2
... Thrombosis now has new ... transformation of complex algorithms ... images into dynamic step-by-step ... precise, up-to-date information for ...
... enable all those involved with healthcare decisions ... very latest evidence in their field of ... each year as the volume of evidence ... delivering the best single source available for ...
Cardiology Intensive Board Review is geared specifically to candidates taking the Cardiovascular Boards and the Cardiovascular section of the Internal Medicine Boards....
... AHA Clinical Cardiac Consult is the ... guidance on the diagnosis and management ... abnormalities. From evaluation of chest pain ... congenital disease, this quick reference makes ...
Medicine Products: