FDA approves new subcutaneous form of Sarclisa for multiple myeloma

FDA has approved Sarclisa Escena (isatuximab-irfc), a new subcutaneous formulation of Sarclisa, for the same multiple myeloma indications as the intravenous formulation. The approval expands treatment delivery options without changing the approved treatment regimens or eligible patient populations.

The new formulation can be administered using the CirCLIQ on-body delivery system or by manual subcutaneous injection. In the pivotal phase 3 IRAKLIA trial, subcutaneous isatuximab demonstrated efficacy and pharmacokinetics comparable to the intravenous formulation when combined with pomalidomide and dexamethasone, supporting a shorter and potentially more convenient administration option for patients and infusion centers. Phase 2 studies also supported use with carfilzomib and dexamethasone and with bortezomib, lenalidomide, and dexamethasone.

The prescribing information includes warnings for hypersensitivity and other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.

"Multiple myeloma is a hematologic malignancy that often requires frequent intravenous infusions or manual subcutaneous injections. Treatment administration can be burdensome for patients while also placing physical demands on healthcare professionals," said Sikander Ailawadhi, MD, Professor of Medicine in the Division of Hematology/Oncology at Mayo Clinic Florida and principal investigator of the IRAKLIA study. "The comparable efficacy demonstrated across multiple studies and the patient-centered design of the on-body injector offer an opportunity to improve the patient experience while maintaining the established efficacy of Sarclisa."

Sources: FDA. (2026 July 9). FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications; Sanofi. 2026 July 10. Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector