Navigation Links
Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer
Date:9/10/2009

r earlier
  • The reaction was mild in most patients, resolving in 1 to 2 weeks
  • The reaction can be severe and debilitating in some patients, resulting in discontinuation of therapy
  • DOXIL is an irritant, not a vesicant; use precautions to avoid extravasation
  • DOXIL can cause fetal harm when used during pregnancy
  • Recall reaction has occurred with DOXIL administration after radiotherapy
  • DOXIL may interact with drugs known to interact with the conventional formulation of doxorubicin HCl
  • In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) >20% (DOXIL vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%)
    • In addition, 19% vs 52.3% reported alopecia (all grades)
    • Grade 3/4 hematologic ARs reported in >5% (DOXIL vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)
  • In patients with multiple myeloma, the most common all-grade ARs >20% (VELCADE plus DOXIL vs VELCADE, respectively) included: neutropenia (36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%), nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%), constipation (31% vs 31%), mucositis/stomatitis (20% vs 5%), peripheral neuropathy (42% vs 45%), neuralgia (17% vs 20%), and rash (22% vs 18%)
    • In addition, 19% vs <1% reported HFS
  • In patients with AIDS-related Kaposi's sarcoma, ARs reported in greater than or equal to 5% of DOXIL-treated patients were: neutropenia (ANC <1000/mm3, 46%; <500/mm
    '/>"/>

  • SOURCE Centocor Ortho Biotech Products, L.P.
    Copyright©2009 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5

    Related biology technology :

    1. Medarex Announces Extension of Broad Antibody Development Relationship with Centocor
    2. Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
    3. Centocor/Janssen-Cilags Ustekinumab Will Become the Gold Standard for Psoriasis By 2011
    4. Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
    5. Ortho Biotech, L.P. and Centocor, Inc. Alert Authorized Distributors and Prescribing Physicians About Stolen Product
    6. GeneNews provides Centocor access to its osteoarthritis program
    7. Baseline Research Indicates High Interest in Centocor-Ortho Biotechs SIMPONI(R)
    8. Centocor Ortho Biotech Data to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting
    9. Centocor Ortho Biotech Inc. Awarded $1.67 Billion Patent Jury Verdict from Abbott Laboratories
    10. Ortho Biotech Supports FDA Advisory Committees Recommendations on Use of ESAs in Chronic Renal Failure Patients
    11. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:2/27/2015)... South San Francisco, CA (PRWEB) February 27, 2015 ... it is joining forces on February 28 with patients ... globally to raise awareness for Rare Disease Day®. ... of rare diseases and calling attention to the special ... support community around them. , “Cytokinetics is proud to ...
    (Date:2/26/2015)... VIEW, Calif. , Feb. 26, 2015  23andMe, ... of Kate Black as Privacy Officer and ... federal, and state privacy laws as well as health ... regulatory team, she will be responsible for reviewing, updating ... customers in the U.S. and abroad. She joined the ...
    (Date:2/26/2015)... Feb. 26, 2015 DuPont Executive Vice President ... by key research advancements and product launches across the ... of America Merrill Lynch 2015 Global Agriculture Conference. ... building grain supplies the last two years, long-term demand ... pace of the last decade, when demand for corn ...
    (Date:2/26/2015)... , Feb. 26, 2015 BioEnterprise today ... companies have attracted more than $2 billion in growth ... local and national investors, strategic sources, state – including ... half of the $2 billion has been raised in ... comes on the heels of the BioEnterprise Midwest ...
    Breaking Biology Technology:Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 2Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 3Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 4Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 5Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases 623andMe Appoints Kate Black as Privacy Officer and Corporate Counsel 2DuPont Leader Outlines Path for Growth in Agriculture and Nutrition & Health Segments 2DuPont Leader Outlines Path for Growth in Agriculture and Nutrition & Health Segments 3DuPont Leader Outlines Path for Growth in Agriculture and Nutrition & Health Segments 4DuPont Leader Outlines Path for Growth in Agriculture and Nutrition & Health Segments 5More Than $2 Billion Invested in Northeast Ohio Bioscience Start-Up Companies Since 2002 2More Than $2 Billion Invested in Northeast Ohio Bioscience Start-Up Companies Since 2002 3More Than $2 Billion Invested in Northeast Ohio Bioscience Start-Up Companies Since 2002 4
    ... more states line up to promote human embryonic stem-cell research, ... all? The most likely answer is no. But among those ... may be the best positioned for success. , ,Thats because ... not aimed at advancing stem-cell research alone, but an interdisciplinary ...
    ... City blends handheld computer gameplay into a real environment, ... Co-Lab. Madison, Wis. Firefighters need ... their first high-rise fire. City officials need to respond ... to the right place. Military teams need to work ...
    ... commerce ,Wisconsin Governor Jim Doyle has appointed Mary Burke, ... planning for Trek Bicycles , to be the state's ... stepped down at the end of 2004 to take a ... January 31 ,Governor Doyle's business-plan contest will stop accepting ...
    Cached Biology Technology:Life-science research plan is about more than stem cells 2Life-science research plan is about more than stem cells 3How games have evolved to provide real-world education 2How games have evolved to provide real-world education 3How games have evolved to provide real-world education 4
    (Date:2/5/2015)... Jan. 30, 2015  It is gratifying to see ... potential for genomic science as a means to better ... and treatment.  I was honored to participate in today,s ... medicine program. Since the 1980s my ... genomics—from the first sequenced genome of a free living ...
    (Date:1/22/2015)... 13, 2015  Today, FreeWavz ( www.FreeWavz.com ), the ... campaign on Fundable, https://www.fundable.com/freewavz . FreeWavz will ... capacity to meet customer demand. Logo ... http://photos.prnewswire.com/prnh/20150113/168790 Invented by Dr. ...
    (Date:1/22/2015)... NEW YORK and POINT ROBERTS, Washington ... global news source covering leading sectors including technology and tech ... Personal Privacy marketplace featuring master pickpocket and security consultant ... wallet is stolen and talks about the Wocket™ biometric smart ...
    Breaking Biology News(10 mins):J. Craig Venter, Ph.D., Co-Founder and CEO, Human Longevity, Inc. (HLI) Participates in White House Precision Medicine Event 2FreeWavz Launches on Fundable to Drive Speed-to-Market in 2015 2Apollo Robbins Talks about the Illusion of Personal Safety and How Easily Your Wallet is Stolen; If a Wocket Wallet is Stolen the Thief Can't do Anything With it! 2Apollo Robbins Talks about the Illusion of Personal Safety and How Easily Your Wallet is Stolen; If a Wocket Wallet is Stolen the Thief Can't do Anything With it! 3
    ... Hopkins researchers report that two proteins best known for ... liver into a sugar-producing factory when food is scarce. ... problem in people with diabetes, the proteins' interaction might ... disease, the researchers say. , Under normal circumstances, the ...
    ... March 3 issue of Nature, Johns Hopkins researchers report ... actually come together to turn the liver into a ... production of sugar is a damaging problem in people ... for future drugs to fight the disease, the researchers ...
    ... evidence that birds can be deceived by camouflage in the ... Nature [3 March 2005]. , The idea that bold contrasting ... by many armies as long ago as the First World ... long been used to explain how insects such as moths ...
    Cached Biology News:Eliminate Data Analysis Bottlenecks in Drug Discovery 2Eliminate Data Analysis Bottlenecks in Drug Discovery 3PHACCS, an online tool for estimating the structure and diversity of uncultured viral communities using metagenomic information 2PHACCS, an online tool for estimating the structure and diversity of uncultured viral communities using metagenomic information 3
    ... CRF The antibody blocks ... sequence that it was raised ... found in the paraventricular hypothalamic ... colchicine treated 4% FA perfused ...
    ... siSolutions siRNA Custom Synthesis Service ... duplex RNA to knockdown any ... (19 RNA base pairs with ... 27-mers, or other lengths of ...
    ... 100 IS System is ideal for developing ... reagents. This system contains the new, improved, ... Luminex. The user can design specific templates ... system has fully integrated graphing and data ...
    Polyclonal Antibody to HADHB...
    Biology Products: