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:1/22/2015)... January 22, 2015 Eckert & Ziegler ... Spectrometry (AMS) services to the pharmaceutical and biotech industry, ... the company in the position of Director of Science ... broad and valuable experience in drug metabolism and bioanalysis ...
(Date:1/22/2015)... 2015  Transwestern | RBJ today announces the firm brokered a ... Shire a leading biopharmaceutical company, at Two Ledgemont Center in ... Robert Richards , president, and Brian Cohen , senior ... five-floor building at 95 Hayden Ave. Photo - ...
(Date:1/22/2015)... CO / Rootstown, OH (PRWEB) January 22, 2015 ... detection platform, announced today that it has received AOAC-PTM Certifications ... O45, O1O3, O111, O121, and O145; collectively referred to as ... coli) O157, at 1 colony forming unit (cfu) per 325 ...
(Date:1/22/2015)... 2015 Controlled Substance Compliance Services (CSCS), ... companies check the legal requirements around using controlled substances ... , As their international operations expand and become ... solutions built as a result of the first phase ...
Breaking Biology Technology:Eckert & Ziegler Vitalea Science appoints Mark Seymour, PhD as Director of Science & Technology 2Eckert & Ziegler Vitalea Science appoints Mark Seymour, PhD as Director of Science & Technology 3Transwestern?RBJ Advises Shire in 202,000 SF Lease, Creating Boston's Largest Suburban Biotech Campus 2Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Detection of “Big 6” E.coli Food Pathogens 2Global Compliance Service for Controlled Substances to Expand to China 2
... a developer of follow-on biologics and biopharmaceuticals, announced,today that ... Stewart Fourth Annual Growth Conference on Thursday, July 10, ... conference will take place at the Mandarin Oriental Hotel ... July 10. Insmed,s,presentation will be webcast live over the ...
... Inc.,(Nasdaq: ATSI ), manufacturer and marketer of ... has obtained new in vivo,data to support the ... Heart Valve., (Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO ), ... in Lausanne, Switzerland,on May 4, 1992 by Professor ...
... July 8, 2008Biotech and pharmaceutical firms are developing ... the complicated drug discovery process, reports Genetic ... Most successful approaches rely on a combination of ... tools, according to an article in the July ...
Cached Biology Technology:Insmed to Present at Collins Stewart Fourth Annual Growth Conference 2ATS Medical Confirms Excellent Durability of the ATS Open Pivot Mechanical Heart Valve 2
(Date:12/11/2014)... 2014 Research and Markets , ... has announced the addition of the "Biometrics Market ... One major trend emerging in this ... technology, it is important to upgrade biometric solutions to ...
(Date:12/11/2014)... 10, 2014  That blood pressure plays a role in human ... the medical term for high blood pressure – was first ... inflatable cuff that,s used in measuring blood pressure was invented ... new about hypertension, its triggers and its effects. In fact, ...
(Date:12/10/2014)... 8, 2014 You,ve been here before: you desperately need to ... site key or the answer to your secret question. What,s your ... Today, Hoyos Labs , a digital infrastructure security company, launches ... the frustration that comes with usernames, passwords and PINs – ...
Breaking Biology News(10 mins):Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2Research points to need for new approaches to treatment of high blood pressure 2Research points to need for new approaches to treatment of high blood pressure 3Research points to need for new approaches to treatment of high blood pressure 4The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3
... nanoparticles, tiny pieces of gold so small that they ... in electronics, healthcare products and as pharmaceuticals to fight ... the nanoparticles requires dangerous and extremely toxic chemicals. While ... of nanoparticles in the near future, researchers have been ...
... Can a road-trip across eastern North America, ancient ice sheets, ... trees? Julie Godbout and colleagues from the Universit Laval, ... Canada to collect samples from jack pine trees would shed ... genetics. About 20,000 years ago, ice sheets covered ...
... genetic material. Endogenous retroviruses (ERV) are those sequences derived ... that, being incorporated in the genome, are transmitted from ... the expression of ERV can benefit the host if ... the protection of the embryo. However, given its pathogenic ...
Cached Biology News:Cinnamon can replace harmful chemicals used to create nanoparticles 2Blast from the past: Jack pine genetics support a coastal glacial refugium 2Blast from the past: Jack pine genetics support a coastal glacial refugium 3Ph.D. thesis describes 35 hitherto unknown families of endogenous retroviruses 2
Component in MasterPure™ Purification Kits...
Mouse monoclonal [TU-20] to beta III Tubulin (FITC) ( Abpromise for all tested applications). entrezGeneID: 10381 SwissProtID: Q13509...
Phospho-FKHR (Thr24)/FKHRL1 (Thr32) Antibody...
Mouse anti-Insulin-Like-3 Class: Antibody Product Group: Adipokine and Obesity related...
Biology Products: