FDA Approves Isatuximab On-Body Injector, Raising Anti-CD38 Competition in Myeloma

The FDA has approved an on-body injector for Sanofi’s isatuximab (Sarclisa), launching a new phase of competition in anti-CD38 regimens in multiple myeloma. Sanofi announced the approval, which applies to all existing indications of isatuximab’s intravenous (IV) formulation.¹

The product, to be called Sanofi Escena, will be the first cancer therapy approved for administration through both an on-body injector (OBI) and manual subcutaneous (SC) administration. However, studies have shown that the OBI method offers safety advantages and is preferred by nurses, who do not have to manually administer the injection.²

In its statement, Sanofi said, “Sarclisa Escena administered via the CirCLIQ OBI offers the potential to change the overall patient experience” in multiple myeloma treatment. “The hands-free automated injector may also streamline the administration process for providers by potentially reducing the physical burden on nurses and providing more freedom for patient monitoring and interaction.”¹

The approval is supported by the phase 3 IRAKLIA noninferiority study (NCT05405166), which showed that OBI administration offered similar efficacy, pharmacokinetics, and safety compared with IV infusion, as well as much shorter treatment time and fewer infusion-related reactions.³

About 36,000 patients are diagnosed with multiple myeloma in the United States each year, according to the American Cancer Society.⁴ In recent years, standard of care for these patients has included a 3-step process: induction therapy to reduce myeloma cells, an autologous stem cell transplant (for eligible patients), and maintenance therapy. In the induction phase, patients can receive triplet or quadruplet therapy anchored by an anti-CD38 therapy, either isatuximab or daratumumab (Darzalex; Johnson & Johnson).

For years, isatuximab saw rival daratumumab gain market share with the introduction of its subcutaneous formulation (Darzalex Faspro). Experts have told The American Journal of Managed Care^® that they anticipate approval of a subcutaneous option for isatuximab to revive discussion about the relative advantages of the 2 therapies.

Sikander Ailawadhi, MD, an oncologist and drug development specialist at Mayo Clinic, Jacksonville, Florida, led IRAKLIA. In an interview with The American Journal of Managed Care®, he said the important discussion is less about the 2 anti-CD38 therapies and more about a whole new delivery system—one completely different than anything seen previously. He rattled off all the advantages. “The fact that it is hands-free, the fact that is automated, controlled, [has] an extremely high success rate of the injection, [is] convenient, comfortable, with a flat dose …”

This last point is perhaps overlooked: the OBI formulation of isatuximab is 1400 mg regardless of body weight, Ailawadhi noted, meaning it’s far easier to administer than other options. “We now have a much more patient-centric array of options,” he said.

The OBI device was developed by Enable Injections, which has designed injection devices in other conditions; in 2023, its Empaveli with pegcetacoplan for paroxysmal nocturnal hemoglobinuria saw 90% of new patients opt for this delivery method in 4 months.⁵

Having isatuximab available with an on-body injector “represents a significant advancement in multiple myeloma care,” said Donna D. Catamero, ANP-BC, OCN, CCRC, associate director, Myeloma Research; adjunct faculty for Mount Sinai Phillips School of Nursing; and International Myeloma Foundation Nurse Leadership Board member. “For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients.”¹

Asked to comment on feedback from nurses to the OBI delivery, Ailawadhi said, “They have said they really like it. They find it very convenient. A nurse could apply that, and for the duration of the injection, they could be charting. The workflows are different,” he explained. “There has been overwhelmingly positive feedback from the nurses, and through the nurses we are also hearing about the patient experience.”

In IRAKLIA, which was the first phase 3 study to use OBI in the treatment of myeloma, the use of OBI isatuximab with pomalidomide and dexamethasone (Isa-Pd) brought a 71.1% objective response rate, compared with 70.5% for IV Isa-Pd, establishing noninferiority (relative risk 1.008; 95% CI: 0.903-1.126) in adult patients with relapsed or refractory MM (R/R MM) who have received at least 1 prior line of treatment.³

The overall safety profile of the OBI combination was consistent with the established safety profile of the IV combination. While 25% of patients in the IV group experienced systemic administration reactions, only 1.5% of patients in the OBI group experienced those reactions. No new safety concerns were observed, except for injection site reactions that were seen in 0.4% of OBI injections (n=19/5145 injections). Nearly all injection site reactions were grade 1; one reaction was grade 2.^1,3

Xavier Leleu, MD, PhD, of Hôpital La Mileterie in France commented during the recent European Hematology Association Congress about the potential for the OBI formulation to be used for home administration of isatuximab. Ailawadhi said for now the FDA approval applies only to current approved uses for the therapy. Nonetheless, he said this change has the potential to have a huge impact on the myeloma care delivery landscape.

“This is something that doesn't require a pharmacy hood to prepare,” he said. “It comes in a vial; you can use that vial to load the device even at bedside.” Ailawadhi predicts that the use of the OBI delivery system can free up time and resources in many ways.

“When I'm saying that the impact is going to be on cancer care and healthcare utilization across the board, I'm taking in those kind of benefits, those kind of advantages that are coming,” he said.

This article has been updated.

References

1. Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. News release. Sanofi. July 10, 2026. Accessed July 10, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483
2. McCormick B, Leleu X. Safety, Reliability of SC Isatuximab via OBI in Multiple Myeloma Support Recent EU Approval: Xavier Leleu, MD, PhD. AJMC. June 12, 2026. Accessed July 10, 2026. https://www.ajmc.com/view/safety-reliability-of-sc-isatuximab-via-obi-in-multiple-myeloma-support-recent-eu-approval-xavier-leleu-md-phd
3. Ailawadhi S, Špička I, Lu J, et al. Isatuximab subcutaneous via an on-body delivery system versus isatuximab intravenous, plus pomalidomide and dexamethasone, in relapsed/refractory multiple myeloma: the randomized phase 3 IRAKLIA study. Presented at: 2025 European Hematology Association Congress; June 12-15, 2025; Milan, Italy. Abstract S203
4. Key statistics about multiple myeloma. American Cancer Society. Updated January 13, 2026. Accessed July 10, 2026. https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html
5. Caffrey M. Could on-body delivery of isatuximab bring more competition to anti-CD38 myeloma treatment? Am J Manag Care. 2025;31(Spec 9): Pages: SP556-SP558