Navigation Links
FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
Date:10/16/2007

dvanced breast cancer," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb.

Registrational Trials

The FDA reviewed the efficacy and safety of IXEMPRA based on the analysis of two multi-center, multinational trials that included 878 patients and evaluated IXEMPRA either as a monotherapy or in combination with capecitabine in patients with metastatic or locally advanced breast cancer.

(Phase II, Monotherapy Trial: -081) The single-arm Phase II trial evaluated the efficacy and safety of IXEMPRA as a monotherapy. This study enrolled 126 patients with metastatic or locally advanced breast cancer resistant to three prior therapies (an anthracycline, a taxane and capecitabine). Resistance was defined as disease progression while on therapy in the metastatic setting (defined as progression while on treatment or within eight weeks of last dose) or recurrence within six months of the last dose in the adjuvant or neoadjuvant setting (only for anthracycline and taxane). HER2 positive patients must also have progressed during or after discontinuation of trastuzumab. The primary endpoint was objective response rate, which is an assessment of tumor shrinkage in response to treatment. Results determined by an independent radiology review (IRR) showed an objective partial response of 12.4% (95% CI, 6.9-19.9) in 113 response-evaluable patients.

Treatment-related non-hematological adverse events (greater than or equal to 20%) included: peripheral sensory neuropathy 62% (Grade 3/4: 14%), fatigue/asthenia 56% (Grade 3/4: 13%), myalgia/arthralgia 49% (Grade 3/4: 8%), alopecia 48% (Grade 3/4: 0%), nausea 42% (Grade 3/4: 2%), stomatitis/mucositis 29% (Grade 3/4: 6%), vomiting 29% (Grade 3/4: 1%), diarrhea 22% (Grade 3/4: 1%), and musculoskeletal pain 20% (Grade 3/4: 3%). Treatment-related hematological adverse events (greater than or equal to 20%) included: neutropenia (Gr
'/>"/>

SOURCE Bristol-Myers Squibb Company
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. UW-Madison approves new research institute
2. FDA approves GEs heart-imaging technology
3. Senate approves bill to expand stem cell funding
4. FDA approves advanced digital mammography system
5. Building commission approves Institutes for Discovery
6. UW Board of Regents approves $134 million medical research facility
7. FDA approves Bone Cares Hectorol for treatment of kidney disease
8. Analog people in the Digital Revolution, part II
9. Analog people in the digital revolution
10. Unique Surface Treatment of Novel TSK-GEL ODS Columns Provide Separation of Aqueous and Fat Soluble Vitamins
11. Improve Recovery and Reproducibility with Pre-Treatment of Analytical TSK-GEL G3000SWXL Size Exclusion Columns
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... Proove Biosciences , the commercial and ... a new genetic test built upon research from their ... will provide physicians with an objective way to ... are stratified between individuals. With this new test, physicians ... a genetic predisposition that will affect their pain tolerance. ...
(Date:9/30/2014)... , Sept. 30, 2014  RegeneRx Biopharmaceuticals, ... announced that it has received a Canadian Patent ... Actin-Sequestering Peptides.  This patent includes claims using thymosin ... other actin-sequestering peptides for these purposes.  The patent ... RegeneRx Biopharmaceuticals, Inc. ( www.regenerx.com ) ...
(Date:9/30/2014)... Hungary , September 30, 2014 ... and intuitive browsing of chemistry in documents ... chemistry software solutions and consulting services for life ... chemical information and generate Markush structures from documents. ... an organizations intellectual property, however generating and understanding ...
(Date:9/30/2014)... OriginOil Inc. (OTC/QB: OOIL), developer of Electro ... up large quantities of water, announced today that in ... the launch of the company's CLEAN-FRACâ„¢ industrial grade demonstrator ... STW Resources . , Immediately upon startup, the ... and achieved a 99.8% reduction in Turbidity on flowback ...
Breaking Biology Technology:Proove Biosciences is Now Offering the Proove Pain Perception Genetic Test to Help Physicians Assess Patient Pain Tolerance Levels 2Proove Biosciences is Now Offering the Proove Pain Perception Genetic Test to Help Physicians Assess Patient Pain Tolerance Levels 3RegeneRx Receives Canadian Patent for Inhibition or Reversal of Skin Aging 2ChemAxon Introduces ChemCurator for Chemical Information Extraction and Markush Structure Creation 2OriginOil, Inc. Report to Shareholders: Blue Gold in West Texas 2
... to add new apoA1 measurement and apoB:apoA1 ratio to its, ... ... heart disease, BIRMINGHAM, Ala., Nov. 6 ... its VAP(R),Cholesterol Test in booth No. 2918 at the American Heart ...
... Inc. (Pink,Sheets: SNDY) is pleased to announce that the ... from the St. Mary,s,Hospital in Waterbury, CT. St. Mary,s ... yrs and it has chosen to continue using the,Company,s ... vital role in the history of Greater,Waterbury, providing nearly ...
... Pharmaceuticals, Inc.,(OTC Bulletin Board: ACCP) announced today that it ... Global Investment Conference to be held,November 10-12, 2008 at ... of,Access is scheduled to speak on Tuesday, November 11, ... corporate overview and discuss the Company,s,product opportunities., The ...
Cached Biology Technology:Atherotech to Exhibit VAP(R) Cholesterol Test at American Heart Association Scientific Sessions 2008 2Solos Endoscopy, Inc. Receives Purchase Order from Connecticut Hospital 2Access Pharmaceuticals to Present at the Rodman & Renshaw Annual Global Investment Conference 2
(Date:9/29/2014)... at Washington State University have concluded that nondigestible ... may help prevent disorders associated with obesity. ... assess these compounds in apple cultivars grown in ... of the journal Food Chemistry ., "We ... source of these nondigestible compounds but there are ...
(Date:9/29/2014)... Behavioral Brain Research provides novel insight into ... of chronic alcohol exposure that can lead to disruptions ... research indicate that individuals with alcohol use disorders frequently ... people are actively drinking, when they are going through ... disturbances can last for months, or even years, after ...
(Date:9/29/2014)... Pangea was starting to break up and dog-sized dinosaurs were ... phytosaurs and rauisuchids were at the top of the food ... didn,t interact much as the former was king of the ... are changing, thanks largely to the contents of a single ... the German journal Naturwissenschaften , Stephanie Drumheller ...
Breaking Biology News(10 mins):An apple a day could keep obesity away 2Tooth buried in bone shows prehistoric predators tangled across land, sea 2
... of Oceanography at UC San Diego have developed a ... algae. As reported in this week,s online edition ... Sciences , Scripps graduate student Emily Trentacoste led the ... growth component in biofuel production. In the quest ...
... In what is anticipated to be a major step ... Cell Foundation (NYSCF) Research Institute is partnering with the ... NYSCF scientists will generate stem cell lines from ... researchers to better understand and potentially treat select rare ...
... Smaller bowl sizes may be the next weapon in the battle ... in the Journal of Pediatrics which found children not ... also eat 52 percent more. , "The quickest way parents ... smaller bowl," comments Brian Wansink, professor of behavioral economics and the ...
Cached Biology News:Scripps oceanography researchers engineer breakthrough for biofuel production 2NYSCF and NIH create cell models of rare and undiagnosed diseases 2NYSCF and NIH create cell models of rare and undiagnosed diseases 3
... designed to stabilize the biomolecules during ... There are neither animal proteins ... a convenient 10 times solution in ... to other traditional lyophilizing additives such ...
... benchtop incubator-shaker, has the smallest footprint of all ... 540 x 680 mm (W x D) does ... 505 x 510mm). Available in 25 mm or ... for shaking applications requiring controlled speed and temperature ...
... the smallest thermal cyclers on the market, which ... 0.5ml (20 samples) or 0.2ml microtube (25 samples) ... and cooling rate of 3.6C/sec and 2.0C/sec respectively ... Fast track programming with new quick dial facility ...
... StabilZyme HRP Conjugate Stabilizer is an ... protein and other non-toxic stabilizing chemicals in ... 6.2 6.7. This product contains ... and 20 ppm Proclin 300 (Rohm and ...
Biology Products: