FDA Accepts Biologics License Application for Isatuximab in Resistant Multiple Myeloma
Posted: Wednesday, July 17, 2019
On July 10, 2019, the U.S. Food and Drug Administration (FDA) accepted for review a biologics license application for isatuximab for the treatment of patients with relapsed or refractory multiple myeloma. The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
The biologics license application is based on results from ICARIA-MM (ClinicalTrials.gov identifier NCT02990338), an open-label pivotal phase III clinical trial of isatuximab in patients with relapsed or refractory multiple myeloma. ICARIA-MM is reportedly 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 (Abstract 8004) and the 2019 European Society of Hematology Annual Meeting.
Isatuximab received Orphan Drug designation for relapsed or refractory multiple myeloma from both the FDA and the European Medicines Agency. In the second quarter of 2019, the European Medicines Agency accepted for review a marketing authorization application for isatuximab.
Isatuximab is currently being evaluated in multiple ongoing phase III 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.
