Summary:
- The U.S. Food and Drug Administration (FDA) has approved SARCLISA (isatuximab-irfc) in combination with standard of care treatments for adult patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant.
- SARCLISA is the first anti-CD38 therapy approved in the U.S. for this patient population, providing a new treatment option for those with newly diagnosed multiple myeloma.
- The approval was based on positive results from the Phase 3 IKEMA study, which demonstrated that the SARCLISA combination therapy significantly improved progression-free survival compared to the standard of care alone.