Sanofi BLA Filed for Myeloma
FDA has accepted for review a Sanofi BLA for isatuximab for treating patients with relapsed/refractory multiple myeloma. The investigational monoclonal antibody is designed to target a specific epitope on the CD38 receptor of a plasma cell. The agency has set a user fee review target action date of 4/30. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
The submission is based on data from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with relapsed/refractory multiple myeloma. The company says ICARIA-MM is the first positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone.
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 tumors.