A Biologics License Application (BLA) for an investigational treatment for relapsed/refractory multiple myeloma has been accepted for review by the Food and Drug Administration (FDA).
Isatuximab (Sanofi) is a monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell. The BLA includes data from the ICARIA-MM phase 3 study which included 307 patients with relapsed/refractory multiple myeloma.
Patients were randomized to receive either isatuximab combined with pomalidomide and low-dose dexamethasone or pomalidomide/low-dose dexamethasone (active comparator). Results, which were presented at the American Society of Clinical Oncology Annual Meeting 2019, showed that median progression free survival was 11.5 months for the isatuximab combination group vs 6.5 months for the active comparator, at a median follow-up of 11.6 months.
Isatuximab has previously been granted Orphan Drug designation by the FDA. The Company is also investigating the treatment for other hematological malignancies and solid tumors.
A Prescription Drug User Fee Act target date for the BLA has been set for April 30, 2020.
For more information visit Sanofi.us.