Posted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma.
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 application is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with relapsed/refractory multiple myeloma. ICARIA-MM is the first positive randomised Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone.
