Speciality Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Education Dialogues
    • Business Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Speciality Medical Dialogues
    • Editorial
    • News
        • Anesthesiology
        • Cancer
        • Cardiac Sciences
        • Critical Care
        • Dentistry
        • Dermatology
        • Diabetes and Endo
        • Diagnostics
        • ENT
        • Featured Research
        • Gastroenterology
        • Geriatrics
        • Medicine
        • Nephrology
        • Neurosciences
        • Nursing
        • Obs and Gynae
        • Ophthalmology
        • Orthopaedics
        • Paediatrics
        • Parmedics
        • Pharmacy
        • Psychiatry
        • Pulmonology
        • Radiology
        • Surgery
        • Urology
    • Practice Guidelines
        • Anesthesiology Guidelines
        • Cancer Guidelines
        • Cardiac Sciences Guidelines
        • Critical Care Guidelines
        • Dentistry Guidelines
        • Dermatology Guidelines
        • Diabetes and Endo Guidelines
        • Diagnostics Guidelines
        • ENT Guidelines
        • Featured Practice Guidelines
        • Gastroenterology Guidelines
        • Geriatrics Guidelines
        • Medicine Guidelines
        • Nephrology Guidelines
        • Neurosciences Guidelines
        • Obs and Gynae Guidelines
        • Ophthalmology Guidelines
        • Orthopaedics Guidelines
        • Paediatrics Guidelines
        • Psychiatry Guidelines
        • Pulmonology Guidelines
        • Radiology Guidelines
        • Surgery Guidelines
        • Urology Guidelines
    LoginRegister
    Speciality Medical Dialogues
    LoginRegister
    • Home
    • Editorial
    • News
      • Anesthesiology
      • Cancer
      • Cardiac Sciences
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endo
      • Diagnostics
      • ENT
      • Featured Research
      • Gastroenterology
      • Geriatrics
      • Medicine
      • Nephrology
      • Neurosciences
      • Nursing
      • Obs and Gynae
      • Ophthalmology
      • Orthopaedics
      • Paediatrics
      • Parmedics
      • Pharmacy
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
    • Practice Guidelines
      • Anesthesiology Guidelines
      • Cancer Guidelines
      • Cardiac Sciences Guidelines
      • Critical Care Guidelines
      • Dentistry Guidelines
      • Dermatology Guidelines
      • Diabetes and Endo Guidelines
      • Diagnostics Guidelines
      • ENT Guidelines
      • Featured Practice Guidelines
      • Gastroenterology Guidelines
      • Geriatrics Guidelines
      • Medicine Guidelines
      • Nephrology Guidelines
      • Neurosciences Guidelines
      • Obs and Gynae Guidelines
      • Ophthalmology Guidelines
      • Orthopaedics Guidelines
      • Paediatrics Guidelines
      • Psychiatry Guidelines
      • Pulmonology Guidelines
      • Radiology Guidelines
      • Surgery Guidelines
      • Urology Guidelines
    • Home
    • News
    • Cancer
    • FDA approves novel...

    FDA approves novel antibody-drug conjugate for common non-Hodgkin lymphoma

    Written by Hina Zahid Published On 2019-06-11T19:10:05+05:30  |  Updated On 11 Jun 2019 7:10 PM IST
    FDA approves novel antibody-drug conjugate for common non-Hodgkin lymphoma
    Food and Drug Administration, FDA has approved novel antibody-drug conjugate for diffuse large B-cell lymphoma, a common type of on-Hodgkin lymphoma.

    The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. Polivy is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.


    More than 18,000 people are diagnosed with DLBCL each year in the U.S. Although it can be cured, about 30 to 40% of patients suffer a relapse. This type of cancer grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs. Signs and symptoms of DLBCL may include swollen lymph nodes, fever, recurring night sweats and weight loss.


    “Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells,” said Richard Pazdur, M.D., director of the Food and Drug Administration, FDA Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the Food and Drug Administration, FDA Center for Drug Evaluation and Research. “Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked.”


    Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (called CD79b) found only on B cells (a type of white blood cell), then releases the chemotherapy drug into those cells. Efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.


    The most common side effects of Polivy plus BR include low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.


    Health care professionals are advised to monitor patients closely for infusion-related reactions, low blood counts and fatal and/or serious infections. Health care professionals should also monitor patients for tumor lysis syndrome (a complication from many tumor cells being killed off at the same time), liver damage (hepatotoxicity) and progressive multifocal leukoencephalopathy (PML), fatal or life-threatening infection of the brain. FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Polivy and for three months after the last dose. Women who are pregnant or breastfeeding should not take Polivy because it may cause harm to a developing fetus or newborn baby.


    Polivy in combination with BR was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Polivy’s clinical benefit.


    The Food and Drug Administration, FDAgranted this application Breakthrough Therapy and Priority Review designations. Polivy also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Polivy to Genentech.


    Bone marrowcancerchemoimmunotherapycommondiarrheadiffuse large B-cell lymphomaDLBCLFDAFDA Approvesmultifocal leukoencephalopathynon-Hodgkin lymphomaNovelpneumoniapolatuzumab vedotin-piiqPolivyRichard Pazdurswollen lymph nodesUS Food and Drug Administrationweight loss

    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

    Hina Zahid
    Hina Zahid
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

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

      Website Last Updated On : 12 Oct 2022 7:06 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