Sanofi Receives FDA Approval for Sarclisa Plus VRd in Frontline Multiple Myeloma

Sanofi today announced that the FDA has approved Sarclisa (isatuximab-irfc) plus bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. In the Phase 3 IMROZ trial, Sarclisa plus VRd demonstrated a statistically significant improvement in progression-free survival compared to VRd alone. This approval makes Sarclisa the first anti-CD38 antibody approved in combination with VRd for frontline transplant-ineligible myeloma.