Navigation Links
Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
Date:8/27/2008

PDGFR alpha fusion kinase-negative or unknown; adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP); patients with KIT (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). The effectiveness of Gleevec in GIST is based on objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Important safety information(7)

Fetal harm can occur when Gleevec is administered to a pregnant woman; therefore, women of childbearing potential should be advised to not become pregnant while taking Gleevec tablets and to avoid breast-feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants. Sexually active female patients taking Gleevec should use adequate contraception. If the patient does become pregnant while taking Gleevec, the patient should be advised of the potential hazard to the fetus.

In adult Ph+ CML patients, severe (NCI Grades 3/4) lab abnormalities -- including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%) and hepatotoxicity (approx 5%) -- and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and musculoskeletal pain (2%-9%) were reported among patients receiving Gleevec*. Severe fluid retention appears to be dose-related, was more common in the advanced-phase studies (where the dosage was 600 mg/day), and is more common in the elderly.

* Numbers indicate the range of percentages in 4 studies among adult patients with Ph+ CML in blast crisis, accelerated phase, and chronic phase.

In HES/CEL patients, instances of Grade 3 leukopenia, neutropenia, lymphopenia, and anemia were reported.

For DFSP, severe (NCI Grades 3/4) lab abnormali
'/>"/>

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:
*Name:
*Comment:
*Email:
(Date:12/16/2009)... -- Capitalizing on the continued strong growth ... venture capital market, leaders from BioCrossroads, Eli Lilly ... University, Purdue University, the University of Notre Dame, ... announced the establishment of the INext Fund, a ... Organized through BioCrossroads, Indiana,s initiative to grow, expand ...
(Date:12/16/2009)... -- Sequenom, Inc. (Nasdaq: SQNM ), today ... Mr. David Pendarvis to its board of directors. ... Kenneth F. Buechler, Ph.D., was president, chief scientific ... to 1994, Dr. Buechler was Biosite,s director of ... a senior research scientist for the diagnostics research ...
(Date:12/16/2009)... Germany, December 16 Eppendorf has ... and Verigene(R) SP systems for,infringement of European ... "Method for the,identification and/or the quantification of ... and all imports of the respective products ... authorities are required to confiscate any,violating products. ...
(Date:12/15/2009)... SAN MARINO, Calif., Dec. 15 Epeius ... of targeted genetic medicine, gained international validation of ... Rexin-G , when scientists around the world ... be a major locus of cancer pathogenesis and ... anti-cancer therapies. Recently, scientists at the NIH National ...
Breaking Biology Technology:Indiana Industry, University and Community Leaders Capitalize on Next Generation of State's Life Sciences Growth 2Indiana Industry, University and Community Leaders Capitalize on Next Generation of State's Life Sciences Growth 3Indiana Industry, University and Community Leaders Capitalize on Next Generation of State's Life Sciences Growth 4Indiana Industry, University and Community Leaders Capitalize on Next Generation of State's Life Sciences Growth 5Sequenom Appoints Two New Board Members 2Sequenom Appoints Two New Board Members 3Eppendorf Successfully Initiates Import ban Against Nanosphere, Inc. for the Countries of the European Union 2Scientists Rediscover Gene Target for Cancer Therapy 2Scientists Rediscover Gene Target for Cancer Therapy 3
... 25 NuVasive, Inc. (Nasdaq:,NUVA), a medical device company ... the spine, announced today,details relating to its fourth quarter ... on Tuesday, February 19, 2008, after,the close of the ... Tuesday, February 19, 2008 at,5:30 p.m. ET / 2:30 ...
... Arena Pharmaceuticals,Inc. (Nasdaq: ARNA ) announced today that ... of a second generation oral niacin receptor agonist,under a ... of atherosclerosis and other disorders. The initiation of this,trial ... very pleased with the progress of this collaboration,investigating the ...
... 24 ,Exelixis, Inc. (Nasdaq: EXEL ) announced today ... of Exelixis, will present at,the 2008 Wachovia Healthcare Conference ... January 31, 2008., The presentation will be webcast ... Investors on the Exelixis website at, http://www.exelixis.com ., ...
Other Biology Technology:NuVasive Announces Webcast and Conference Call of Fourth Quarter and Full Year 2007 Results 2NuVasive Announces Webcast and Conference Call of Fourth Quarter and Full Year 2007 Results 3Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Second Generation Niacin Receptor Agonist Under Its Collaboration With Merck & Co., Inc. 2Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Second Generation Niacin Receptor Agonist Under Its Collaboration With Merck & Co., Inc. 3
(Date:12/15/2009)... Extinct woolly mammoths and ancient American horses may ... several thousand years longer than previously thought. After ... Alaska, a team of researchers used cutting-edge techniques ... in permafrost samples dated to between 7,600 and ... at least one population of these now-extinct mammals ...
(Date:12/15/2009)... and economic toll on society. It is estimated that ... in U.S. waters and it,s likely that rip currents account ... disconnect exists between rip current research and public understanding. ... and more importantly, most people do not know how to ... The goal of the Rip Current Symposium is to identify ...
(Date:12/14/2009)... AlaskaScientists have identified a novel antifreeze molecule in a ... 100 degrees Fahrenheit. Unlike all previously described biological antifreezes ... little or no protein. It is composed of a ... new places within the cells of organisms. , ... this molecule is a whole new kind of antifreeze ...
Breaking Biology News(10 mins):Late-surviving megafauna exposed by ancient DNA in frozen soil 2Late-surviving megafauna exposed by ancient DNA in frozen soil 3Late-surviving megafauna exposed by ancient DNA in frozen soil 4Scientists isolate new antifreeze molecule in Alaska beetle 2AIMS Benefit Solutions Offering Long Term Care Insurance Featuring CASH First 28TM 29 from United of Omaha 62932 1AIMS Benefit Solutions Offering Long Term Care Insurance Featuring CASH First 28TM 29 from United of Omaha 62932 2AIMS Benefit Solutions Offering Long Term Care Insurance Featuring CASH First 28TM 29 from United of Omaha 62932 3Your Online Resource For Plastic Surgery Information 62930 1Your Online Resource For Plastic Surgery Information 62930 2Statement of HDMA President and CEO John M Gray on the Importation of Prescription Drugs 62928 1Statement of HDMA President and CEO John M Gray on the Importation of Prescription Drugs 62928 2
... owls. The variation in individual circadian rhythms ... fact. But, until now, to systematically study circadian ... underlying genetic causes), scientists have had to rely ... and identify circadian rhythm variations in humans, the ...
... A common chemical used in the manufacturing and pharmaceutical ... and prevent heart failure in mice with the genetic ... at the University of Michigan Medical School. , The ... of skeletal muscles seen in people with MD. But ...
... discovered that chickens raised for meat can choose whether ... themselves or their eggs. , That phenomenon of 'reproductive ... out how to deal with less productive hens that ... bodies. "They like to be a little bit more ...
Other Biology News:A novel method to measure circadian cycles 2Chemical 'band-aid' prevents heart failure in mice with muscular dystrophy 2Chemical 'band-aid' prevents heart failure in mice with muscular dystrophy 3Chemical 'band-aid' prevents heart failure in mice with muscular dystrophy 4What comes first…the chicken, the egg, or the bad attitude? 2
... MULTI-FUN Incubator is a compact benchtop ... a microprocessor controller with a large ... and agitation speed. Air circulation inside ... incubator. Temperature can be easily calibrated ...
... siTrio siRNA --- a cocktail of ... gene of interestis our most popular product. ... than 75% knockdown of your target gene ... siRNA for transfection and confirmation of optimal ...
... --- a cocktail of 3 siRNAs specifically ... our most popular product. The siTrio reagent ... of your target gene when used under ... and confirmation of optimal transfection with one ...
... is a compact benchtop and stackable ... controller with a large display screen ... speed. Air circulation inside to evenly ... can be easily calibrated from the ...
Biology Products: