FDA Reviewing Isatuximab for Multiple Myeloma

July 10, 2019 – The FDA has accepted a Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma, according to Sanofi, the manufacturer of the anti-CD38 monoclonal antibody. The BLA is based on the phase III ICARIA-MM trial, in which adding isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death compared with pomalidomide and … (leggi tutto)