U.S. License Holder:
Sanofi Aventis US
Date of License:
March-02-2020
Last Update:
Nov-15-2024
FDA-Approved Indications
SARCLISA (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated:
In combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor;
In combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy;
In combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).