Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Latest News
    • Roche gets USFDA nod...

    Roche gets USFDA nod for combo lymphoma treatment Polivy

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-06-11T09:30:07+05:30  |  Updated On 16 Aug 2021 12:11 PM IST

    Polivy was approved in combination with Roche's older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell lymphoma (DLBCL) whose cancer has worsened despite at least two previous lines of therapy.


    New Delhi: The U.S. Food and Drug Administration on Monday granted earlier-than-expected approval to Roche Holding AG's antibody-drug conjugate Polivy for treatment of patients with advanced lymphoma.


    Polivy was approved in combination with Roche's older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell lymphoma (DLBCL) whose cancer has worsened despite at least two previous lines of therapy.


    Antibody-drug conjugates are designed to deliver toxic chemotherapy directly to tumours.


    Read Also: Roche, Spark Therapeutics $4.3 billion deal delayed again amid US, UK scrutiny


    Roche said the average U.S. list price for a four-month course of Polivy would be $90,000. Rituxan is priced at $39,500 for four months.


    Wall Street analysts estimate Policy sales at nearly $1 billion by 2024, according to IBES data from Refinitiv.


    Side effects seen in studies of Polivy included low blood cell counts, nerve damage, fatigue and pneumonia, the FDA said in a statement.


    Cell therapy Yescarta, from Gilead Sciences Inc and Kymriah and sold by Novartis AG, is also approved for patients with advanced DLBCL.


    Dr Matthew Matasar, a haematologist at New York's Memorial Sloan Kettering Cancer Center who was involved in the development of Policy, said the drug could be an option for some patients to try before determining whether they need to move on to CAR-T treatments.


    He said Polivy can only be used once due to the risk of serious neurotoxicity.


    Read Also: Roche, GE Healthcare launch NAVIFY Tumor Board to enable personalised treatment decisions in cancer care


    Roche estimates that nearly 25,000 new cases of DLBCL, a type of non-Hodgkin's lymphoma (NHL), will be diagnosed in the United States this year.


    NHL, which is one of the most common cancers, accounts for about 4% of all types of cancers in the United States, according to the American Cancer Society.


    Continued approval for the treatment may depend on data from a confirmatory trial, Roche said.


    The FDA's accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

    antibody drugantibody drug conjugate Polivyblood cell countscancerCAR T treatmentschemotherapyDLBCLDr Matthew Matasarfatigueiffuse large B cell lymphomlymphoma treatmentnerve damageNHLnon-Hodgkin's lymphomaNovartis AGPneumoniaPolivyRituxanRocheRoche Holding AGstreatmentUnited StatesUSFDAUSFDA approval
    Source : Reuters

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok