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:4/17/2015)... 2015 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: SQD; OTCQX: ... develops and commercializes proprietary technologies and products for ... has received approval from the TSX Venture Exchange ... share purchase warrants ("the Warrants") of the Company, ... May 2013 private placement financing. Each ...
    (Date:4/17/2015)... 17, 2015  US-Australian drug discovery company, Novogen, today ... Understanding with the Feinstein Institute for Medical Research ... to collaborate with the objective of developing ... collaboration brings together the drug discovery expertise of ... the Feinstein Institute in neurosciences and oncology. ...
    (Date:4/17/2015)... 2015 LC Sciences LLC, a ... today that it is seeking beta testers for ... PCR based targeted sequencing technology. The system offers ... enables accurate detection of rare variants. It utilizes ... The company will collaborate with beta testers to ...
    (Date:4/16/2015)... Spirax Sarco, the leader in ... newly designed, state-of-the-art website in the first quarter ... promotes the Spirax Sarco brand, company capabilities, and ... a site visitor might be looking for including ... serviced, the latest company news, careers, and much ...
    Breaking Biology Technology:SQI Diagnostics to Extend Warrant Expiry 2SQI Diagnostics to Extend Warrant Expiry 3Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 2Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 3Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 4Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 5Novogen and Feinstein Institute Join Forces to Find Effective Treatments for Brain Cancer 6LC Sciences Seeks Beta Testers of Targeted Sequencing Method Ahead of Q4 Launch 2LC Sciences Seeks Beta Testers of Targeted Sequencing Method Ahead of Q4 Launch 3Spirax Sarco website has a new look 2
    ... BEIJING, July 16 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Amex:, ... in China, announced today,that its Annual General Meeting originally scheduled ... , At the July 16, 2009 ... outstanding shares was not present. In accordance with Antigua,law, the ...
    ... week are marking major breakthroughs in the effort to ... than 200 million people worldwide and causes long-term debilitating ... documents a multinational success, led by a team at ... the genome of the Schistosoma mansoni blood fluke, which ...
    ... , , , ... that it had closed its series A financing round. The infusion of capital ... that converts a wide variety of cellulosic materials (such as algae, plants and ... , As part of the agreement, the lead investor has joined ...
    Cached Biology Technology:Sinovac Adjourns 2008 Annual General Meeting 2UCSF researchers help crack parasite genome, identify drug leads 2UCSF researchers help crack parasite genome, identify drug leads 3
    (Date:4/14/2015)... , April 14, 2015  HYPR Corp. ... Online (FIDO ® ) Alliance tm , an ... FIDO members commit to share technology and collaborate ... that are interoperable, more secure and private, and ... biometric identity verification that protects sensitive user information ...
    (Date:4/9/2015)... April 9, 2015 Synaptics Inc. (NASDAQ: SYNA ... today that it will report financial results for the ... 2015, after the close of market. The company will ... at 2:00 p.m. PT (5:00 p.m. ET), during which ... participate on the live call, analysts and investors should ...
    (Date:4/2/2015)... Sweden , April 2, 2015 ... for Q1 2015 attributed to somewhat higher than 125 ... in the year-end report 2014 that revenues for Q1 ... that the company reported for Q4 2014. The operating ... to be negative. The complete interim report will as ...
    Breaking Biology News(10 mins):HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3Synaptics to Report Third Quarter Results on April 23 2Fingerprint Cards Revises Revenues for Q1 2015 2
    ... the first researchers to study the deadly link between ... Association lifetime achievement award today at a ceremony in ... endocrinologist James Sowers, MD, recognizes his more than 30 ... The Irvine Page-Alva Bradley Lifetime Achievement Award in ...
    ... it they,re very good at what they do. But ... out inspection work in oily or dangerous environments, or in ... they,re one of the fastest and most maneuverable creatures on ... speeds due to their streamlined bodies and a finely tuned ...
    ... , New Rochelle, NY, September 19, 2012 Many ... will largely be based on the field of ... News ( GEN ) ( http://genengnews.com ). ... larger arrays of biosamples, demand is exceeding supply, ...
    Cached Biology News:Pioneering researcher receives Heart Association Lifetime Achievement Award 2Pioneering researcher receives Heart Association Lifetime Achievement Award 3Robotic tuna is built by Homeland Security 2
    Nuclear/Cytosol Fractionation Kit Research Focus: other Storage Temperature: 4C Shipping Temperature: 4C...
    Cytosol/Particulate Rapid Separation Kit Research Focus: other Storage Temperature: -20C Shipping Temperature: 4C...
    Request Info...
    Purified anti-human CD182 (CXCR2)...
    Biology Products: