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Isatuximab Approval Status

FDA Approved: No
Generic name: isatuximab
Company: Sanofi
Treatment for: Multiple Myeloma

Isatuximab is an investigational monoclonal antibody targeting a specific epitope on the CD38 receptor in development for the treatment of relapsed/refractory multiple myeloma (RRMM).

Development Status and FDA Approval Process for isatuximab

DateArticle
Jul 10, 2019FDA to Review Isatuximab as a Potential Treatment for Relapsed/Refractory Multiple Myeloma
Jun  2, 2019Phase 3 Trial of Isatuximab Combination Therapy Showed 40% Reduction in the Risk of Disease Progression or Death for Patients with Relapsed/Refractory Multiple Myeloma
Dec  5, 2016Sanofi Genzyme Announces Start of Phase III Study of Isatuximab for Relapsed and Refractory Multiple Myeloma

Further information

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