OnCo
drugsProductApproved2020🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Isatuximab

Isatuximab is Sanofi's CD38 antibody, approved in frontline transplant-ineligible myeloma (IMROZ) and, from July 2026, as an under-the-skin injection.

ICARIA-MM (Isa-Pd), IKEMA (Isa-Kd), IMROZ (Isa-VRd in transplant-ineligible newly diagnosed: PFS HR 0.60; approved September 2024). Subcutaneous on-body delivery (Sarclisa Escena) approved July 2026.

Schematic of the modality · Monoclonal antibody (anti-CD38) · not a molecule; see the Monoclonal antibodies page
Modality
Monoclonal antibody (anti-CD38)
Mechanism
Chimeric IgG1 anti-CD38 binding a distinct epitope; direct apoptosis without crosslinking plus ADCC/ADCP.
Brand / code
Sarclisa / Sarclisa Escena (SC)
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. The 2025 subcutaneous on-body injector (Sarclisa Escena) is applied in the clinic and stays in Part B.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Cancer Drugs FundNICE TA658 · 2020SMC: accepted
Appraised for
With pomalidomide and dexamethasone for myeloma after 3 or more treatments
Notes
With carfilzomib and dexamethasone (IKEMA) appraised 2023.
Cancer Drugs Fund
Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA658 · NHS England Cancer Drugs Fund list · SMC advice: isatuximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 20 Sept 2024ApprovalUS

    IMROZ frontline

  2. Jul 2026ApprovalUS

    Subcutaneous on-body injector

Approvals

RegionYearIndication
US2020Relapsed myeloma with pomalidomide-dexamethasone; 2021 with carfilzomib-dexamethasone
US2024Newly diagnosed transplant-ineligible with VRd (IMROZ)
US2026Subcutaneous formulation (Sarclisa Escena)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
87 studies26 recruiting70 Phase 220 Phase 3
Search “Isatuximab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Isatuximab
intervention: Isatuximab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend65 papers in the last 12 months-28% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Isatuximab" OR ABSTRACT:"Isatuximab" OR TITLE:"Sarclisa" OR ABSTRACT:"Sarclisa" OR TITLE:"Sarclisa Escena" OR ABSTRACT:"Sarclisa Escena") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Isatuximab, not a curated reading list.

Connected

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