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    • USFDA to review Sanofi...

    USFDA to review Sanofi isatuximab for treatment of multiple myeloma

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-07-21T09:15:51+05:30  |  Updated On 16 Aug 2021 11:14 AM IST

    Sanofi Isatuximab targets a specific epitope on the CD38 receptor. It is designed to trigger multiple, distinct mechanisms of action that are believed to directly promote programmed tumour cell death (apoptosis) and immunomodulatory activity.


    PARIS: Drugmaker Sanofi recently said that the U.S. Food and Drug Administration (USFDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.


    The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. ICARIA-MM is the first positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone. Results from this trial were presented at the 2019 American Society of Clinical Oncology Annual Meeting and the 2019 European Society of Hematology Annual Meeting.


    Read Also: Biovac finalizes deal to manufacture Pfizer, Sanofi vaccines


    Multiple myeloma is the second most common hematologic malignancy1, affecting more than 138,0002 people worldwide. Multiple myeloma results in significant disease burden. Patients with multiple myeloma continue to relapse over time making it a difficult to treat and incurable malignancy.


    Isatuximab targets a specific epitope on the CD38 receptor. It is designed to trigger multiple, distinct mechanisms of action that are believed to directly promote programmed tumour cell death (apoptosis) and immunomodulatory activity.


    Isatuximab received the orphan designation for relapsed/refractory multiple myeloma from both the FDA and the European Medicines Agency (EMA), and in the second quarter of 2019, the EMA accepted for review the Marketing Authorization Application.


    Isatuximab is currently being evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with relapsed/refractory or newly-diagnosed multiple myeloma. It is also under investigation for the treatment of other hematologic malignancies and solid tumours. Isatuximab is an investigational agent and its safety and efficacy have not been fully evaluated by any regulatory authority.


    Read Also: Sanofi gets European nod for Libtayo to treat cutaneous squamous cell carcinoma

    apoptosisBLACD38 receptordexamethasoneEMAepitopeFDAICARIA-MMisatuximabmalignancy1myelomapharmapharma companypharma newsRRMMSanofiUSFDA

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    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

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