Japan Approves Subcutaneous Formulation of Sanofi's Sarclisa for Multiple Myeloma, Marking Second Global Regulatory Win

Sanofi announced on June 19, 2026 that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted approval for Sarclisa subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM).¹ The approval covers three distinct indications: in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib for relapsed or refractory MM (R/R MM), and in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed MM (NDMM) in adult patients.¹

What is the clinical significance of the subcutaneous formulation?

Multiple myeloma is an incurable plasma cell malignancy accounting for approximately 10% of hematologic cancers, with an estimated 176,000 new cases diagnosed globally each year.² Treatment typically involves prolonged, multi-agent regimens administered in repeated clinic visits over months to years, placing a logistical and physical burden on patients and healthcare systems.² Anti-CD38 monoclonal antibodies, including isatuximab and daratumumab, have become foundational components of MM treatment across newly diagnosed and relapsed settings, improving survival outcomes but requiring frequent clinical attendance when administered intravenously.³

The clinical and operational case for subcutaneous reformulation extends beyond isatuximab. Speaking with BioPharm International at the AAPS National Biotechnology Conference 2026, Charles Theuer, MD, PhD, chief medical officer at Halozyme, described how IV-to-SC transitions have dramatically compressed administration time across oncology and other therapeutic areas. "You decrease the administration time, literally from hours to minutes and sometimes as little as seconds," Theuer said.⁸ While his comments were not specific to isatuximab, they reflect the delivery science rationale that has driven Sanofi's SC reformulation program and a broader industry shift toward patient-centric biologic administration.

The approval of a subcutaneous formulation addresses one of the most persistent practical barriers in MM care — the burden of extended IV infusion visits. Sarclisa SC is administered as a fixed 1,400 mg dose, compared to the weight-based 10 mg/kg IV formulation, and can be delivered either via manual SC injection or, pending a separate regulatory decision, via the CirCLIQ on-body injector (OBI) developed by Enable Injections using its enFuse platform.¹ A regulatory submission for the OBI remains under review in Japan; if approved, Sarclisa SC would become the first anticancer treatment administered via an OBI in Japan, and the first MM medicine in the country to offer both manual SC injection and OBI administration.¹

What did the IRAKLIA trial show?

The Japan approval is supported by results from the Phase 3 IRAKLIA trial (NCT05405166), a multicenter, randomized, open-label study comparing SC isatuximab administered via OBI to IV isatuximab, each in combination with pomalidomide and dexamethasone, in patients with R/R MM who had received at least one prior line of therapy.⁴

The study met both coprimary endpoints of non-inferiority in objective response rate (ORR) and observed isatuximab concentration before dosing (Ctrough) at steady state.⁴ ORR was 71.7% in the SC arm versus 70.5% in the IV arm (risk ratio 1.008; 95% CI, 0.903–1.126; P = .0006), confirming clinical equivalence between formulations.⁵ Key secondary endpoints were also met, including very good partial response rates, Ctrough at cycle 2, and infusion reaction incidence. Systemic infusion reactions occurred in 1.5% of patients in the SC arm versus 25% in the IV arm — a meaningful tolerability advantage.⁵

"The consistent overall response rate and comparable efficacy and safety profile observed in the IRAKLIA study for subcutaneous Sarclisa represent an exciting advancement, offering insight into a potential new administration option for patients," said Sikander Ailawadhi, MD, professor of medicine in the division of hematology/oncology at Mayo Clinic Florida and principal investigator of the IRAKLIA trial.⁶

Where does the regulatory rollout stand globally?

Japan's approval is the second global regulatory endorsement of Sarclisa SC, following EU approval on June 8, 2026 — the first time an on-body injector has been approved for an anticancer therapy anywhere in the world.⁷ In the US, the FDA is reviewing a BLA for Sarclisa SC with a PDUFA goal date of July 23, 2026, following a delay from the original review timeline.⁷ Regulatory submissions are also planned or underway in additional countries.¹

Isatuximab has now been approved in nearly 60 countries across four indications for NDMM and R/R MM, and Sarclisa-based regimens have been prescribed to more than 70,000 patients worldwide.¹ The SC formulation, if approved in the US, would extend the drug's practical utility further — particularly in community oncology settings where infusion chair capacity and scheduling constraints can limit access to IV anti-CD38 therapies.

References

1. Sanofi's Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma. (2026 Jun 19). Sanofi. https://www.globenewswire.com/news-release/2026/06/19/3314694/0/en/press-release-sanofi-s-sarclisa-subcutaneous-formulation-approved-in-japan-for-patients-with-multiple-myeloma.html
2. Palumbo A, Anderson K. (2011 Mar 17). Multiple myeloma. N Engl J Med. https://www.nejm.org/doi/full/10.1056/NEJMra1011442
3. Rajkumar SV. (2022 Aug). Multiple myeloma: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. https://pubmed.ncbi.nlm.nih.gov/35560063/
4. Ailawadhi S, Spicka I, Lu J, et al. (2025 May 28). 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. https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7506
5. Subcutaneous isatuximab earns EU approval in multiple myeloma. (2026 Jun). CancerNetwork. https://www.cancernetwork.com/view/subcutaneous-isatuximab-earns-eu-approval-in-multiple-myeloma
6. Ailawadhi S, quoted in: Subcutaneous Sarclisa shows non-inferiority to IV version for multiple myeloma in phase III IRAKLIA trial. Applied Clinical Trials Online. https://www.appliedclinicaltrialsonline.com/view/subcutaneous-sarclisa-multiple-myeloma-iraklia-trial
7. Mirasol F. (2026 Jun 9). EC approves Sanofi's subcutaneous isatuximab for multiple myeloma across all existing indications. BioPharm International. https://www.biopharminternational.com/view/ec-approves-sanofi-subcutaneous-isatuximab-multiple-myeloma-across-existing-indications
8. Schoenthaler E, Theuer C. (2026 May 14). IV-to-subcutaneous drug reformulations gain momentum through streamlined regulatory pathways. BioPharm International. https://www.biopharminternational.com/view/iv-to-subcutaneous-drug-reformulations-gain-momentum-through-streamlined-regulatory-pathways