Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors Aft... (section or removal of their tumors.Of th...)

HOME >> BIOLOGY >> TECHNOLOGY

Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery

Date:8/27/2008

section, or removal of their tumors. Of those who have the surgery, about half will suffer a recurrence(4). If approved for this indication, Gleevec will be the first treatment option available to GIST patients after surgery to reduce the risk of disease recurrence or to possibly prevent the disease from returning.

"The dramatic clinical results from this study of Gleevec in the adjuvant GIST setting are especially encouraging when we consider the incremental benefit we typically see with other adjuvant therapies for solid tumors," said Rainer Boehm, MD, Executive Vice President, North American Region Head, Novartis Oncology. "The adjuvant use of Gleevec, if approved, would represent an important advance in the ongoing post-surgery management of GIST."

Gleevec is currently indicated in both the US and EU for the first-line treatment of metastatic or unresectable (inoperable) kit-positive GIST. If approved, the use of Gleevec for the treatment of GIST in the adjuvant setting would add to its eight current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and five other rare diseases. Novartis also has a therapy for the treatment of carcinoid tumors and acromegaly and multiple treatments in the pipeline targeting rare diseases.

Filing data

The study on which the regulatory filing is based compared the recurrence-free survival of GIST patients taking Gleevec 400 mg/day versus placebo for one year immediately following surgery. The results showed that 98% of patients receiving Gleevec remained recurrence free at one year following surgery compared to approximately 82% of those receiving placebo(3). This shows that as a result of adjuvant therapy with Gleevec, there was an 89% reduction in risk of GIST returning(2).

The study, known as ACOSOG Z90001, was conducted at multiple cancer centers throughout the US and Canada, under a Cooperative Research and Development Agreement between Novart
'/>"/>

SOURCE Novartis
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8 9 10 11 12
Related biology technology :

1. Video: Higher Initial Dose of Gleevec Achieved Better Early Responses than Standard Dose for Patients with Chronic Myeloid Leukemia
2. TorreyPines Therapeutics Receives NASDAQ Deficiency Notice
3. Omaxe Infrastructure & Construction Private Ltd Receives LoI for Construction of Allopathic Medical College and Associated Hospital at Saharanpur, UP With Construction Value of Approx 250 Crores
4. Caliper Life Sciences Receives $1.1 Million Task Order from the EPAs ToxCast(TM) Screening Program
5. Biotest Diagnostics Receives FDA Clearance for Full Line of Traditional Blood Bank Reagents
6. BMP Sunstone Receives Production License from the SFDA to Manufacture and Market Pediatric Multivitamin Granules in the PRC
7. XTL Biopharmaceuticals Receives Notice of Non-Compliance with Nasdaq Marketplace Rule Due to Changes in Board Composition
8. CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
9. SGX - Lilly Merger Offer Receives Positive Opinions From Proxy Advisory Firms
10. Angiotech receives CE Mark approval of HemoStream(TM) Chronic Dialysis Catheter
11. Medicsight Receives Brazilian State Food and Drug Administration Approval for ColonCAD Software

Post Your Comments:

(Date:12/16/2009)... The American Filtration and Separations Society will hold its 23rd Annual ... Hyatt Hotel in San Antonio, Texas. To further impact the separation ... we are proud to announce that the 2010 AFS Annual Technical ... , , ... Minneapolis, MN (PRWEB) December 16, 2009 ...

(Date:12/15/2009)... 15 Reportlinker.com announces that a ... its catalogue: ,, The Future ... to 2015, Pipeline Analysis and Reimbursement ... ,, Summary ,, The ... Future of Orphan Diseases Therapeutics - Market ...

(Date:12/15/2009)... The International Society for Medical Publication Professionals (ISMPP) ... to accept abstracts for its 6th Annual Meeting, ... 19-21, 2010. This marks the first time that ... organization to submit an abstract to this increasingly ... EST, January 15, 2010. For submission details, please ...

(Date:12/15/2009)... Law Office has announced the launch of several innovative ... legal services in the current economic climate. The ... opportunity to finance legal services over a period of ... equity in their start-up companies. The second is ... montly payment arrangements over 6 to 12 month period ...

[0] American Filtration and Separations Society to Hold 23nd Annual Technical Conference [0] Reportlinker Adds The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement [0] The International Society for Medical Publication Professionals Announces Call for Abstracts for Its 6th Annual Meeting [0] The Prinz Law Office Launches Innovative New Programs to Aid Cash-Strapped Entrepreneurs and Businesses

... Inc. (Nasdaq: JAZZ ) announced today that it ... affiliate of Lehman Brothers and,certain of the other holders ... $40 million of gross proceeds, expanding the,senior debt outstanding ... the note and warrant purchase agreement bear interest at ...

... LONDON, March 18 In video interviews Said,Darwazah, ... performance,financing and acquisitions, plus what they are expecting ... and vodcasts are available,now on http://www.cantos.com ., ... to do is register at, http://www.cantos.com . Cantos.com, ...

... March 18 Cell Therapeutics, Inc.,(CTI) (Nasdaq: CTIC ; MTAX) management will ... 9:00 AM Pacific Time,(PT) in the Bay Auditorium of the Bell Harbor Conference ... replay after the presentation. The webcast can be accessed at, http://www.celltherapeutics.com ., ... WBBA Invest Northwest Conference ...

Other Biology Technology:Jazz Pharmaceuticals, Inc. Announces Expansion of Senior Debt 2

Jazz Pharmaceuticals, Inc. Announces Expansion of Senior Debt Hikma - 2007 Preliminary Results Interviews With CEO and CFO Cell Therapeutics, Inc. (CTI) Invest Northwest Presentation to be Webcast

(Date:12/14/2009)... -- (Dec. 14, 2009) -- Researchers at Rice University ... single nanoparticle that can be tracked in real time ... tags them with a fluorescent dye and kills them ... first examples from a growing field called "theranostics" that ... diseases in a single procedure. , The research is ...

(Date:12/14/2009)... the Biomedical Engineering Society (BMES) have founded a new ... ). CVET is a forum for ... treatment. The first issue of the new quarterly ... other BMES publications at Springer, Annals of Biomedical ... , Cardiovascular Engineering and Technology will present ...

(Date:12/14/2009)... a defining feature of humans. That,s until examples of tool ... an array of other mammals. Now, a report in the ... Press publication, adds an octopus to the growing list of ... behavioral trick that the researchers call stilt walking. In it, ... "bowls," makes its eight arms rigid, and raises the whole ...

Breaking Biology News(10 mins):Tracking new cancer-killing particles with MRI 2 Biomedical Engineering Society's new journal to be published by Springer 2 Tool use in an invertebrate: The coconut-carrying octopus 2 Wisconsin Department of Transportation Chooses EF Johnson Technologies Inc for Statewide First Responder Communications System in 2413 2 Million Co 63012 1 Wisconsin Department of Transportation Chooses EF Johnson Technologies Inc for Statewide First Responder Communications System in 2413 2 Million Co 63012 2 Wisconsin Department of Transportation Chooses EF Johnson Technologies Inc for Statewide First Responder Communications System in 2413 2 Million Co 63012 3 YM BIOSCIENCES AND THE NATIONAL RESEARCH COUNCIL OF CANADA BIOTECHNOLOGY RESEARCH INSTITUTE 28NRC BRI 29 PRODUCE NEW BREAST CANCER DRUG CANDIDATES 15131 1 YM BIOSCIENCES AND THE NATIONAL RESEARCH COUNCIL OF CANADA BIOTECHNOLOGY RESEARCH INSTITUTE 28NRC BRI 29 PRODUCE NEW BREAST CANCER DRUG CANDIDATES 15131 2 YM BIOSCIENCES AND THE NATIONAL RESEARCH COUNCIL OF CANADA BIOTECHNOLOGY RESEARCH INSTITUTE 28NRC BRI 29 PRODUCE NEW BREAST CANCER DRUG CANDIDATES 15131 3 YM BIOSCIENCES AND THE NATIONAL RESEARCH COUNCIL OF CANADA BIOTECHNOLOGY RESEARCH INSTITUTE 28NRC BRI 29 PRODUCE NEW BREAST CANCER DRUG CANDIDATES 15131 4 YM BIOSCIENCES AND THE NATIONAL RESEARCH COUNCIL OF CANADA BIOTECHNOLOGY RESEARCH INSTITUTE 28NRC BRI 29 PRODUCE NEW BREAST CANCER DRUG CANDIDATES 15131 5 OrBIT Study Long Term Results Show Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation at 12 Months 6890 1 OrBIT Study Long Term Results Show Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation at 12 Months 6890 2 OrBIT Study Long Term Results Show Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation at 12 Months 6890 3 OrBIT Study Long Term Results Show Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation at 12 Months 6890 4

[0] Tracking new cancer-killing particles with MRI [0] Biomedical Engineering Society's new journal to be published by Springer [0] Tool use in an invertebrate: The coconut-carrying octopus

... Institution of Oceanography at UC San Diego has provided ... Oceanography graduate student researcher Loren McClenachan accessed archival photographs ... a drastic decline of so-called "trophy fish" caught around ... paper published online in January and printed in an ...

... Lilly Singapore Centre for Drug Discovery (LSCDD), Singapore,s National ... Sciences (SICS), have teamed up to advance drug discovery ... is one of the institutions of SingHealth, the largest ... subsidiary of the US-based biopharmaceutical company, Eli Lilly and ...

... of organic produce increases with consumers, growers need more ... and Gary R. Cline (retired) of the Land Grant ... designed to investigate options for reducing the presence of ... roots, shoots, and flowers, and transmit the bacterial wilt ...

Other Biology News:Historical photographs expose decline in Florida's reef fish, new Scripps study finds 2 Historical photographs expose decline in Florida's reef fish, new Scripps study finds 3 Singapore research organisations team up to advance drug discovery using brain tumor stem cells 2 Controlling cucumber beetles organically 2

Historical photographs expose decline in Florida's reef fish, new Scripps study finds Singapore research organisations team up to advance drug discovery using brain tumor stem cells Controlling cucumber beetles organically

... unique combination of Coulter volume and ... and accurate cell counting. This flow ... UV, allowing flexible fluorochrome selection for ... only achievable with larger, more expensive ...

... 250 g monoclonal antibody irreversibly crosslinked ... ~13 g of PDH complex from heart ... bovine heart mitochondria for control immunocapture. ,The ... isolation of PDH from small amounts of ...

... PULSin may be superior to transfection in ... transfection, with PULSin you can study lethal ... course of proteins in cells. Likewise, delivery ... than traditional RNA interference experiments. ,With ...

Reacti-Bind DNA Coating Solution...

Biology Products:

CELL LAB QUANTA* Flow Cytometer from Beckman Coulter Mouse Anti-Porcine Pyruvate Dehydrogenase (PDH), complex Immunocapture Kit Monoclonal Antibody, Protein G-Agarose Conjugated, Clone 15D3G9C11 from MitoScience LLC PULSin Protein & Antibody Delivery Reagent from Polyplus Transfection DNA COATING SOLUTION from Pierce Biotechnology, Inc.

Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors Aft...(section or removal of their tumors.Of th...)