Galina Bernstein, Senior Director of Clinical Pharmacology Principal at AzureDelta Consulting Inc., shared on LinkedIn:
“FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications.
On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.
The specific indications approved for Isatuximab-irfc are:
- In combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy 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 one to three prior lines of therapy, and
- In combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant.”
FDA Approves Subcutaneous Isatuximab for Multiple Myeloma
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