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.
- 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.
- Assistance programmes
- Sanofi CareASSIST
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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.
- 20 Sept 2024ApprovalUS
IMROZ frontline
- Jul 2026ApprovalUS
Subcutaneous on-body injector
Approvals
| 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) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.