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FDA set to review Sanofi’s isatuximab for multiple myeloma

July 11, 2019 / Anna Smith

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for isatuximab for a review, for the indication of relapsed/refractory multiple myeloma (RRMM). The drug’s maker Sanofi has announced that the target action date for the FDA decision is April 30, 2020. The drug is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell and its BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase III clinical trial of isatuximab in patients with RRMM. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment, and was found to prolong progression-free survival by five months versus Pomalyst and dexamethasone alone in patients. “We are excited by these results, which repre...