WASHINGTON, July 14, 2026 — The U.S. Food and Drug Administration (FDA) approved a new formulation of isatuximab-irfc (Sarclisa Escena), which can be administered by injection under the skin (subcutaneous) in patients with multiple myeloma.
Healthcare professionals can give the treatment manually or by an automated injector. The new formulation is available for the same multiple myeloma patients who currently are eligible to receive Sarclisa intravenously.
“This marks continued progress in making effective therapies more accessible and manageable for people living with blood cancer,” said Lore Gruenbaum, Ph.D., Chief Scientific Officer of Blood Cancer United. “Subcutaneous administration may reduce the time patients spend receiving therapy and could lessen the burden of repeated intravenous infusions, particularly for those on long-term treatment regimens.”
Isatuximab works by targeting a protein called CD38. Blood Cancer United funded research that identified this protein as a promising drug target because it is commonly found on myeloma cancer cells. This discovery paved the way for isatuximab and other immune-based therapies for multiple myeloma.
New formulation offers similar efficacy and safety as intravenous treatment
Data from a 500-patient trial showed that response rates to treatment with the subcutaneous delivery of isatuximab were comparable to the delivery of the drug intravenously. Safety was also comparable to the intravenous version.
Findings from two additional trials demonstrated that patients with relapsed or refractory disease treated with subcutaneous isatuximab in combination with carfilzomib and dexamethasone achieved an overall response rate of nearly 80%, and that patients with newly diagnosed multiple myeloma treated with subcutaneous isatuximab in combination with bortezomib, lenalidomide, and dexamethasone achieved an overall response rate of 97.3%.
Together results from these three trials supported the FDA approval of subcutaneous isatuximab for all three indications for which the intravenously delivered version was already approved.
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