Frequently asked questions on the FDA's approval of Sarclisa SC (isatuximab-irfc), in combination with multiple myeloma indications
On Thursday, July 9, the U.S. Food and Drug Administration (FDA) approved subcutaneous Sarclisa (isatuximab-irfc) for multiple myeloma indications. For the benefit of patients, care partners, and their care team, the International Myeloma Foundation has prepared this FAQ to address some questions you may have in mind.
What is Sarclisa SC (isatuximab-irfc)?
Sarclisa SC (isatuximab-irfc) refers to subcutaneous (SC) isatuximab-irfc used in combination with multiple myeloma indications.
It can be administered using the CirCLIQ on-body delivery system (OBDS/on-body injector) or by manual subcutaneous administration with a syringe and infusion set.
According to Sanofi, Sarclisa SC (isatuximab-irfc) is the first anticancer treatment in the U.S. that is approved for administration through an on-body injector, and the first multiple myeloma treatment available by both on-body injector and manual subcutaneous administration.
What are the specific indications for the FDA-approved Sarclisa SC (isatuximab-irfc)?
The FDA approved Sarclisa SC (isatuximab-irfc) for adult patients with multiple myeloma in all current indications approved by the FDA for isatuximab:
- In combination with pomalidomide and dexamethasone (SC-Pd): for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
- In combination with carfilzomib and dexamethasone (SC-Kd): for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
- In combination with bortezomib, lenalidomide and dexamethasone (SC-VRd): for patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant.
What efficacy and safety information from the FDA should myeloma patients take note of?
The FDA approval was supported by clinical studies showing high overall response rates across the approved treatment combinations. In the IRAKLIA study, the overall response rate (ORR) was 71.1% with subcutaneous isatuximab-irfc and 70.5% with intravenous isatuximab-irfc, demonstrating non-inferior efficacy. The IZALCO study reported an ORR of 79.7%, while the IsaSocut study reported an ORR of 97.3%.
The FDA prescribing information for Sarclisa SC (isatuximab-irfc) also includes warnings and precautions for hypersensitivity and other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.
What is the recommended dosage for Sarclisa SC (isatuximab-irfc)?
The FDA-recommended dose for Sarclisa SC (isatuximab-irfc) is 1,400 mg, administered as a subcutaneous injection using either the CirCLIQ on-body delivery system (OBDS) or manual administration with a syringe and infusion set, in combination with the approved treatment regimen.
What is the overall safety profile for subcutaneous Sarclisa-Pd?
According to the FDA and the IRAKLIA Phase 3 study, the overall safety profile of subcutaneous Sarclisa-Pd was consistent with the established safety profile of intravenous Sarclisa-Pd, with no new safety concerns identified except for injection-site reactions associated with subcutaneous administration.
In IRAKLIA, systemic administration reactions occurred in 25% of patients receiving intravenous Sarclisa-Pd compared with 1.5% of patients receiving subcutaneous Sarclisa-Pd. Injection-site reactions occurred in 0.4% of on-body injector injections (19 of 5,145 injections), with nearly all being Grade 1 and one reported Grade 2 event.
What are common and possible adverse reactions/side effects of Sarclisa SC (isatuximab-irfc)?
For subcutaneous Sarclisa-Pd, the most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea.
Additionally, the most common hematology laboratory abnormalities for subcutaneous Sarclisa-Pd (≥40%) were decreased leukocytes, decreased neutrophils, decreased lymphocytes, decreased platelets, and decreased hemoglobin.
The FDA prescribing information for Sarclisa SC (isatuximab-irfc) also includes warnings and precautions for hypersensitivity reactions, other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.
What notable clinical trial results became the basis for the FDA approval of Sarclisa SC (isatuximab-irfc)?
The FDA approval was supported by three clinical studies evaluating Sarclisa SC (isatuximab-irfc) in different treatment settings.
- The pivotal Phase 3 IRAKLIA trial (NCT05405166) enrolled 531 patients and demonstrated non-inferior efficacy of Sarclisa SC (isatuximab-irfc) plus pomalidomide and dexamethasone compared with the intravenous formulation, with an overall response rate (ORR) of 71.1% versus 70.5%, respectively. The study also showed comparable pharmacokinetics, with a steady-state trough concentration geometric mean ratio (SC/IV) of 1.53 (90% CI: 1.32–1.78).
- Additional support came from the Phase 2 IZALCO study (NCT05704049), in which 74 patients with relapsed and/or refractory multiple myeloma treated with Sarclisa SC (isatuximab-irfc) plus carfilzomib and dexamethasone achieved an ORR of 79.7% (95% CI: 68.8–88.2)
- Phase 2 IsaSocut study (NCT05889221), where 74 transplant-ineligible patients with newly diagnosed multiple myeloma treated with Sarclisa SC (isatuximab-irfc) plus bortezomib, lenalidomide, and dexamethasone achieved an ORR of 97.3% (95% CI: 90.6–99.7).
What are some myeloma expert opinions about Sarclisa SC (isatuximab-irfc)?
The FDA approval announcement included expert comments from investigators and nursing leaders. These statements describe potential benefits but do not change the FDA-approved indications or prescribing information.
Dr. Sikander Ailawadhi, Professor of Medicine at Mayo Clinic Florida and principal investigator of the IRAKLIA study, stated that myeloma treatments often require frequent intravenous infusions or manual subcutaneous injections, which can be burdensome for patients and providers. He said the comparable efficacy observed across multiple studies, together with the patient-centered design of the on-body injector, provides an opportunity to improve the treatment experience while maintaining Sarclisa SC’s (isatuximab-irfc) established efficacy.
Donna D. Catamero, Associate Director of Myeloma Research and a member of the International Myeloma Foundation Nurse Leadership Board, stated that the CirCLIQ on-body injector represents a notable advancement in treatment delivery. She said the automated system has the potential to reduce administrative burden for healthcare professionals, simplify therapy administration, and allow healthcare teams more time for patient monitoring and interaction.
These comments reflect the experts' perspectives on treatment administration and workflow. The FDA approval itself was based on clinical evidence demonstrating efficacy, pharmacokinetics, and safety of Sarclisa SC (isatuximab-irfc) across the approved treatment settings.
References:
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. U.S. Food and Drug Administration news release. July 9, 2026.
Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. Sanofi press release. July 10, 2026.