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Isatuximab is Sanofi's CD38 antibody, approved in frontline transplant-ineligible myeloma (IMROZ) and, from July 2026, as an under-the-skin injection.
Isatuximab is a chimeric IgG1 antibody against CD38 that binds a distinct epitope from daratumumab and kills plasma cells through direct apoptosis without crosslinking as well as ADCC and ADCP. It was approved in 2020 with pomalidomide-dexamethasone (ICARIA-MM) and in 2021 with carfilzomib-dexamethasone (IKEMA) for relapsed myeloma. In IMROZ, adding isatuximab to VRd in transplant-ineligible newly diagnosed patients cut progression with a PFS HR of 0.60 and 60-month PFS of 63.2% versus 45.2%, leading to approval in September 2024. A subcutaneous on-body delivery system (Sarclisa Escena) was approved in July 2026, removing long intravenous infusions. Sanofi develops it; the main competitive question is how it compares with daratumumab, which reached the frontline quadruplet setting first. It is the second CD38 antibody, now usable from diagnosis in older patients not having a transplant.
Backbone ribbon from PDB 4CMH. RCSB PDB 4CMH. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Chimeric IgG1 anti-CD38 binding a distinct epitope; direct apoptosis without crosslinking plus ADCC/ADCP. Connects to CD38.
1.Isatuximab binds CD38.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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.
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.
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.
IMROZ frontline
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications source
Subcutaneous on-body injector
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Relapsed myeloma with pomalidomide-dexamethasone; 2021 with carfilzomib-dexamethasone |
| US | 2024 | Newly diagnosed transplant-ineligible with VRd (IMROZ) |
| US | 2026 | Subcutaneous formulation (Sarclisa Escena) |
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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.
Shares CD38 antibody added to PI-IMiD-dex (quadruplet induction), Newly diagnosed multiple myeloma, transplant-ineligible, Monoclonal antibodies, Multiple myeloma.
Shares IMROZ, CD38, Monoclonal antibodies, Multiple myeloma.
Shares Smouldering multiple myeloma, Newly diagnosed multiple myeloma, transplant-ineligible, Newly diagnosed multiple myeloma, transplant-eligible, Multiple myeloma.
Shares CD38 antibody added to PI-IMiD-dex (quadruplet induction), CD38, Newly diagnosed multiple myeloma, transplant-ineligible, Multiple myeloma.
Shares IMROZ, CD38, Newly diagnosed multiple myeloma, transplant-ineligible, Multiple myeloma.
Shares CD38 antibody added to PI-IMiD-dex (quadruplet induction), CD38, Newly diagnosed multiple myeloma, transplant-eligible, Multiple myeloma.
Shares Newly diagnosed multiple myeloma, transplant-ineligible, Newly diagnosed multiple myeloma, transplant-eligible, Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares Newly diagnosed multiple myeloma, transplant-ineligible, Newly diagnosed multiple myeloma, transplant-eligible, Relapsed or refractory multiple myeloma, Multiple myeloma.