Sanofi Receives FDA Approval for Sarclisa in Frontline Multiple Myeloma

Sanofi today announced that the FDA has approved Sarclisa (isatuximab-irfc) in combination with 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. The 4-year PFS rate was 63.2% for Sarclisa plus VRd versus 45.2% for VRd. This approval expands Sarclisa's use into the frontline setting for transplant-ineligible patients with newly diagnosed multiple myeloma.