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

ents with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury
  • In the randomized multiple myeloma study, 25 patients (8%) in the VELCADE for Injection arm and 42 patients (13%) in the VELCADE plus DOXIL arm experienced left ventricular ejection fraction decrease (defined as absolute decrease greater than or equal to 15% over baseline or a greater than or equal to 5% decrease below institutional lower limit of normal)
  • Myelosuppression may occur; frequently monitor complete blood count (including platelet count), at least prior to each dose of DOXIL
    • In patients with recurrent ovarian cancer or AIDS-related Kaposi's sarcoma, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL
    • In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL and/or VELCADE
    • Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage
    • Sepsis occurring during neutropenia has resulted in discontinuation of treatment and in rare cases of death
  • DOXIL may potentiate the toxicity of other anticancer therapies, especially hematologic toxicities, when used in combination with other therapies that suppress bone marrow
  • Hand-foot syndrome (HFS) may occur during therapy with DOXIL
    • Based on HFS toxicity grade, dose reduction, or delay in administration, or discontinuation of DOXIL may be required
    • HFS was generally observed after 2 to 3 cycles of treatment, but may occu
      '/>"/>

    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:12/19/2014)... --Research and Markets ( http://www.researchandmarkets.com/research/fhh9rj/technology ) ... Innovations in Smart Fabrics (Technical Insights)" report ... http://photos.prnewswire.com/prnh/20130307/600769 The Research Service titled ... assessment on technological advancements and market for Smart ... 1. The Smart Fabrics market is expected to ...
    (Date:12/19/2014)... CAMBRIDGE, MA (PRWEB) December 18, 2014 ... adults in the United States suffer from one or ... arthritis, asthma, or cancer. Medication can address some of ... to daily activities that many sufferers face. While implanted ... surgery and stimulate the whole nerve, which can induce ...
    (Date:12/19/2014)... , Dec. 18, 2014  Decision Resources Group ... dental biomaterial market will grow moderately through 2023 as ... and growing awareness of dental biomaterials all spur procedure ... such as China and ... bring dental procedures within reach for a larger proportion ...
    (Date:12/17/2014)... Based on the revenues gained from surgical imaging ... by four major players contributing to approximately 74% ... GE Healthcare (U.K.), Siemens AG (Germany), Philips (Netherlands), ... Copy at http://www.marketsandmarkets.com/Market-Reports/surgical-imaging-market-210534462.html , The leading ... its strong product portfolio, which includes its flagship ...
    Breaking Biology Technology:Technology Innovations in Smart Fabrics (Technical Insights) 2Draper Wins GSK Funding for Smaller, Smarter Implantable Devices 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 3Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 2Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 3Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 4
    ... Antibodies Establish Exclusive Distribution ... ... an exclusive partnership with Atlas Antibodies to,distribute Prestige Antibodies(TM) -- developed ... research communities.,Initially consisting of 1800 antibodies, the library is expected to ...
    ... 14 Telik, Inc.,(Nasdaq: TELK ) announced that ... Thursday, February 21, 2008 at 4:30 p.m. Eastern time ... of the company,s,financial results for the fourth quarter and ... will be accessible via Telik,s website at, http://www.telik.com ...
    ... (NTI(R)) (Nasdaq: NTII ) today announced the date ... held on Tuesday, March 4,2008. The event will take ... Hotel, 80 Columbus Circle, 36th Floor, South Salon, in ... be Viprinex(TM) (ancrod), NTI,s compound,for the treatment of acute ...
    Cached Biology Technology:Sigma-Aldrich Announces New Prestige Antibodies(TM) Line for Proteomics and Cell Biology Researchers 2Sigma-Aldrich Announces New Prestige Antibodies(TM) Line for Proteomics and Cell Biology Researchers 3
    (Date:12/10/2014)... , Dec. 9, 2014  Valencell, a leader in ... seeing a staggering demand from its licensees for highly ... revealed, is not solely coming from fitness and health ... "A wearable is only as useful as ... is the ultimate driver in long-term mass consumer adoption ...
    (Date:12/5/2014)... Calif. , Dec. 4, 2014 ... has boosted investments in new testing and inspection ... also given rise to a range of innovative ... the requirements of Generation Y, which is generally ... As a result, product development strategies of test ...
    (Date:11/21/2014)... , November 18, 2014 According ... Market by Systems (Video, RFID, Access Control, Intrusion Detection, ... Hotels, Banks, Government), Component Service Geography - Global Forecasts ... Market is projected to be around $25 Billion in ... 2020, growing at a CAGR of 8.69%. ...
    Breaking Biology News(10 mins):Wearable Technology Products Demand Highly Accurate Biometric Technology 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4Industrial Security Systems Market Worth $38 Billion by 2020 2Industrial Security Systems Market Worth $38 Billion by 2020 3
    ... have discovered a type of cell that may contribute to ... sclerosis and rheumatoid arthritis strike women more frequently than men. ... which bind to and attack the body,s own tissue. The ... journal Blood , that they found higher levels of ...
    ... available in Spanish . U.S. Department ... food-aid product called Instant Corn Soy Blend that supplements ... led by food technologist Charles Onwulata at the Agricultural ... at the agency,s Eastern Regional Research Center (ERRC) in ...
    ... Researchers demonstrate for the first time that programmed cell ... themselves - is involved in mandibular regression in termites. ... to pay for the formation of termites, defensive organs, ... University of Toyama, and Shinichi Yoda from the University ...
    Cached Biology News:B-cell discovery suggests why women suffer more autoimmune disease 2Researchers develop fully cooked food-aid product 2Cells die so defensive organs can live 2
    ...
    Standard 2" and 3" Fiberboard Boxes can be sold separately or with 16, 25, 36, 49, 64, 81 or 100 cell dividers. Fiberboard boxes can also be ordered with corresponding freezer racks...
    Whole blood is collected from mice (Swiss Webster, 8-10 weeks old,either sex) and processed within 45 minutes of collection. The complement is then filtered and pooled on ice, bottled and stored at -...
    ... Immunogen : Recombinant human ... 5mg/ml BSA, 0.15M NaCl, 0.05% ... of glycerol to 30% Quality ... on acid extracts of murine ...
    Biology Products: