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:7/30/2015)... 30, 2015 According to a ... Molecular Modeling, PB/PK, PKPD, Trial Design, Toxicity Prediction, In-house, ... Clinical Trial), by End Users - Global Forecast to ... to reach USD 2,107.99 million by 2020 from USD ... Browse more than 75 ...
    (Date:7/30/2015)... KANSAS CITY, Kan. , July 30, 2015 ... PETX ), a pet therapeutics company focused on ... products for companion animals, today announced that its ... results from a dose confirmation study of AT-016, ... to Aratana for the treatment of osteoarthritis pain ...
    (Date:7/30/2015)... 2015  With over 60,000 customers across the globe, ISN improves the efficiency and ... with more than 60,000 safe and reliable contractors in over 80 countries. ... ... Over 60,000 Worldwide Customers ... Headquartered in Dallas, TX , ISN has ...
    (Date:7/30/2015)... -- HIGHLIGHTS:Q2 2015 Results (all changes are ... sales were $697 million compared to $701 million in ... 8%, and changes in foreign currency exchange rates decreased ... , By business unit, organic sales growth was ... SAFC Commercial. , Reported diluted EPS was $0.98 ...
    Breaking Biology Technology:Biosimulation Market Worth 2,107.99 Million USD by 2020 2Biosimulation Market Worth 2,107.99 Million USD by 2020 3Biosimulation Market Worth 2,107.99 Million USD by 2020 4Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 2Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 3Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 4Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 5ISN Reaches Over 60,000 Worldwide Customers 2ISN Reaches Over 60,000 Worldwide Customers 3Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 2Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 3Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 4Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 5Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 6Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 7Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 8Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 9Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 10Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 11Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 12Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 13Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 14Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 15Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 16Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 17Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 18Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 19Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 20
    ... 13 /PRNewswire-Asia-FirstCall/ -- Tianyin,Pharmaceutical Co., Inc., (NYSE AMEX: ... Chinese medicine ("TCM") based in Chengdu, China, today,announced that ... and Drug,Administration (SFDA) to produce Sanqi Tablets in dosage ... Jiedu Tablets in,dosage form of 0.5 gram/tablet (SFDA approval ...
    ... , , CARLSBAD, ... a specialized laboratory services provider, today announced the Company,s participation at ... The Islands Hotel in Newport Beach, CA on August 18, 2009. ... of Investor Relations at Genoptix, will present at the conference on ...
    ... 13 Amsterdam Molecular,Therapeutics (Euronext: AMT), a leader in the field of ... 2009. , , Highlights, - Start ... in Canada following two previous clinical trials, - Presentation ... a clinically important health benefit, accomplished by a significant, ...
    Cached Biology Technology:Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Sanqi Tablets and Yinqiao Jiedu Tablets 2Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Sanqi Tablets and Yinqiao Jiedu Tablets 3Genoptix Announces Participation at the 2009 Southern California Investor Conference 2Amsterdam Molecular Therapeutics Reports Half Year Results 2009 2Amsterdam Molecular Therapeutics Reports Half Year Results 2009 3Amsterdam Molecular Therapeutics Reports Half Year Results 2009 4
    (Date:6/24/2015)... June 24, 2015 The biologics safety testing ... drivers for the market include growth of the pharmaceutical ... drug launches. Over the years, the number of drug ... and 2010, the FDA approved 225 drug applications and ... Europe accounted for 3,822 of ...
    (Date:6/24/2015)... , June 22, 2015 ... announced the addition of the "Huawei Ascend ... report to their offering. Huawei,s ... to the opposite direction than Apple,s and Samsung,s ... fingerprint sensor developed by Fingerprint Cards, a main ...
    (Date:6/23/2015)... 22, 2015 Research ... of the "Body-Worn Temperature Sensors Market - ... Forecast 2014 - 2020" report to their ... of the global body-worn temperature sensors market. The ... on the basis of types, care setting, patient ...
    Breaking Biology News(10 mins):Biological Safety Testing Market by Application, Product, & Test - Global Forecast to 2019 2Biological Safety Testing Market by Application, Product, & Test - Global Forecast to 2019 3Biological Safety Testing Market by Application, Product, & Test - Global Forecast to 2019 4Huawei Ascend Mate 7 Fingerprint Sensor - Reverse Costing Analysis 2Body-Worn Temperature Sensors Market - Global Industry Analysis 2
    ... Researchers at the RIKEN Plant Science Center (PSC) have ... in the model plant Arabidopsis protects cells from harmful ... the journal PLoS Genetics , the finding contributes ... biological processes in both plants and animals, opening the ...
    ... seals often encounter murky water that impedes their vision; ... Extending their vibration-sensitive whiskers, the mammals are almost as ... if guided by sight. Wolf Hanke and his colleagues ... how harbour seals perceive the world through their flow-sensitive ...
    ... 2011 UT Southwestern Medical Center researchers have discovered a ... to a treatment to keep cancer cells from spreading. ... 1 (Rasip1) is so specific and central to so many ... form, said Dr. Ondine Cleaver, assistant professor of molecular biology ...
    Cached Biology News:Discovery of DNA silencing mechanism reveals how plants protect their genome 2Seals sense shapes using their whiskers to feel wakes 2UT Southwestern researchers find protein that might be key to cutting cancer cells' blood supply 2
    synphilin-1 (V-19)...
    Anti-OSMR Monoclonal Antibody Research Focus: cytokine/growth factor Storage: 4C Shipping Temperature: 4C...
    Rat monoclonal [HEK/1/85a] to CCR5 ( Abpromise for all tested applications). entrezGeneID: 1234 SwissProtID: P51681...
    Mouse monoclonal [LPL4A.1] to Plastin L ( Abpromise for all tested applications). SwissProtID: P13796...
    Biology Products: