Three multiple myeloma indications were cleared for subcutaneous Sarclisa Escena, covering newly diagnosed transplant-ineligible adults, relapsed or refractory patients after 1 to 3 prior lines, and adults previously treated with lenalidomide and a proteasome inhibitor.
Phase 3 IRAKLIA data in 531 patients backed the broadest prior-treatment use, with subcutaneous isatuximab plus pomalidomide and dexamethasone posting a 71.1% response rate versus 70.5% for IV treatment, meeting noninferiority.
Phase 2 IZALCO and IsaSocut studies supported the other approvals: response rates reached 79.7% in 74 relapsed or refractory patients and 97.3% in 74 newly diagnosed patients aged 65 and older ineligible for transplant.
Sanofi said the 1400 mg/10 mL product can be given manually or through its separately packaged CirCLIQ on-body injector, which it described as the first approved anticancer on-body injector in the US.
Common risks across regimens included infections, fatigue, musculoskeletal pain and blood-count declines, extending CD38-targeted therapy into a more convenient subcutaneous format for multiple myeloma care.
With its new on-body injector, how soon could this cancer therapy truly move from the clinic to patients' homes?
This new injector promises convenience, but will its cost become a new barrier for cancer patients seeking treatment?
Landmark FDA Approval: Sarclisa Escena SC Introduces On-Body Injector for Multiple Myeloma Patients
Overview
On July 9, 2026, the FDA approved Sarclisa Escena (isatuximab-irfc) as a subcutaneous injection for multiple myeloma, marking a major milestone in cancer care. It is the first anticancer treatment in the U.S. available as both an on-body injector (OBI) and manual subcutaneous injection, giving patients more flexibility and convenience. This new delivery method can reduce the need for intravenous infusions, making treatment easier for patients. The approval covers three combination therapies, allowing Sarclisa Escena to address different stages and prior treatments of multiple myeloma, and potentially improving the overall patient experience.