Oncology Experts Discuss On-Body Subcutaneous Isatuximab in Multiple Myeloma

In a recent Oncology Nursing News podcast, Beth Faiman, PhD, MSN, APN-BC, AOCN, FAAN, FAPO, of Cleveland Clinic, and Sikander Ailawadhi, MD, of Mayo Clinic, examined the transition toward automated on-body administration for multiple myeloma treatments.

The discussion followed the U.S. Food and Drug Administration (FDA) approval of subcutaneous isatuximab-irfc (Sarclisa Escena) administered via the CirCLIQ on-body delivery system (OBDS) across all approved multiple myeloma indications. Approved indications include combination regimens with pomalidomide and dexamethasone (Pd) for relapsed or refractory multiple myeloma (RRMM) after at least one prior line of therapy, carfilzomib and dexamethasone (Kd) for RRMM, and bortezomib, lenalidomide, and dexamethasone (VRd) for transplant-ineligible newly diagnosed disease.

Reflecting on historical administration challenges, Ailawadhi explained that early intravenous anti-CD38 monoclonal antibody infusions required lengthy administration times, noting that initial infusions originally "used to take about 8 hours on day one" before moving to shorter schedules. While manual subcutaneous pushes reduced chair times, limitations remained. "The subcutaneous formulation would still take a longer subcutaneous injection, 3 to 5 minutes," Ailawadhi observed. "The nurse has to keep pushing on the syringe, meaning that it's a slow subcutaneous injection." He emphasized the clinical need "to get more patient-friendly options of treatment which could potentially push the envelope and even consider creating a system in which the drug could be administered at home in alternative settings."

From a nursing perspective, Faiman highlighted the physical demands of manual subcutaneous injections. "I see firsthand the physical strain that the nurses will go through with the repeated manual push," Faiman stated. "Forcing these thick liquids through a 24-gauge syringe with some of the manual push technologies can be a burden." She added that manual administration creates "clinic tethering where you're stuck at the bedside" throughout the injection.

The approval of subcutaneous isatuximab-irfc via OBDS was supported by results from the Phase III IRAKLIA trial (NCT05405166). In 531 patients with RRMM, subcutaneous isatuximab-irfc via OBDS demonstrated efficacy noninferiority to intravenous isatuximab-irfc in combination with Pd, achieving an overall response rate (ORR) of 71.1% (95% CI, 65.2–76.5) versus 70.5% (95% CI, 64.7–75.9) in the intravenous arm.

Phase II trials IZALCO (NCT05704049) and IsaSoCut (NCT05889221) supported efficacy across carfilzomib and bortezomib combinations, yielding ORRs of 79.7% and 97.3%, respectively.

Subcutaneous OBDS administration reduced systemic administration reactions 17-fold compared to intravenous infusion (1.5% vs 25.0%; P < .0001). Local injection site reactions occurred in 0.4% of OBDS injections, with 99.9% completing without interruption over a median injection time of 13 minutes.

Patient satisfaction at Cycle 5 Day 15 showed 70.0% of OBDS patients were satisfied or very satisfied versus 53.4% in the intravenous arm (P = .0001).

Ailawadhi noted that low systemic reaction rates enabled protocol provisions in IRAKLIA allowing healthcare providers to administer OBDS at home starting at Cycle 6. The automated delivery device reduces physical nursing burdens and streamlines outpatient myeloma care.

This program was supported by Sanofi, with the editorial content independently created by Oncology Nursing News and OncLive.

References

1. FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. U.S. Food and Drug Administration. July 9, 2026. Accessed September 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications
2. Ailawadhi S, Špička I, Spencer A, et al. Isatuximab subcutaneous by on-body injector versus isatuximab intravenous plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: Phase III IRAKLIA study. J Clin Oncol. 2025;43(22):2527-2537. doi:10.1200/JCO-25-00744 (NCT05405166)
3. Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector [press release]. Sanofi. July 10, 2026. Accessed September 14, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483