FDA Approval Insights: Subcutaneous Isatuximab Via an On-Body Delivery System Represents a “Game-Changer” in Multiple Myeloma: With Douglas W. Sborov, MD, MS
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In today’s episode, we welcomed Douglas W. Sborov, MD, MS, to discuss the significance of the July 2026 FDA approval of isatuximab-irfc (Sarclisa Escena) for subcutaneous injection for multiple myeloma indications. Dr Sborov is a tenured professor of medicine in the Department of Internal Medicine in the Division of Hematology and Hematologic Malignancies and an adjunct associate professor in the Departments of Molecular Pharmaceutics and Biomedical Engineering at the University of Utah Huntsman Cancer Institute (HCI) in Salt Lake City, as well as director of the HCI Hematology Disease Center and Plasma Cell Dyscrasias (PCD) Program, co-leader of the Hematologic Malignancies Clinical Trials Research Group, and member of the HCI Experimental Therapeutics Program and International Myeloma Working Group (IMWG).
As part of the July 10, 2026, approval, subcutaneous isatuximab is indicated for use:
- in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide (Revlimid) and a proteasome inhibitor
- in combination with carfilzomib (Kyprolis) 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 (Velcade), lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant
In our exclusive interview, Dr Sborov outlined how the subcutaneous formulation of isatuximab and the ability to administer the agent via an on-body delivery system could affect patient quality of life. He also detailed key findings from the phase 3 IRAKLIA trial (NCT05405166) that supported the approval and explained how the use of isatuximab may shift in clinical practice following the subcutaneous approval.