FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
The FDA 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 30 April 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 II clinical trial of isatuximab in patients with RRMM. ICARIA-MM is the first positive randomized Phase III 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.
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