# Isatuximab

Source: https://onco.cc/drugs/isatuximab/  
OnCo record `isatuximab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Sarclisa / Sarclisa Escena (SC)
- Modality: Monoclonal antibody (anti-CD38)
- Mechanism: Chimeric IgG1 anti-CD38 binding a distinct epitope; direct apoptosis without crosslinking plus ADCC/ADCP.
- Approvals: 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)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Isatuximab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Isatuximab

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-eligible](https://onco.cc/cancers/myeloma-transplant-eligible/), [Newly diagnosed multiple myeloma, transplant-ineligible](https://onco.cc/cancers/myeloma-transplant-ineligible/), [Relapsed or refractory multiple myeloma](https://onco.cc/cancers/myeloma-relapsed-refractory/), [Smouldering multiple myeloma](https://onco.cc/cancers/smouldering-myeloma/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [CD38](https://onco.cc/targets/cd38/)
- companies: [Sanofi](https://onco.cc/companies/sanofi/)
- trials: [A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory](https://onco.cc/trials/nct05704049/), [IMROZ](https://onco.cc/trials/imroz/), [Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma](https://onco.cc/trials/nct04270409/), [Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple](https://onco.cc/trials/nct04126200/), [Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT](https://onco.cc/trials/nct07764978/), [Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM](https://onco.cc/trials/nct07217184/)
- pairings: [CD38 antibody added to PI-IMiD-dex (quadruplet induction)](https://onco.cc/pairings/cd38-plus-triplet/)
- pathways: [Complement in cancer](https://onco.cc/pathways/complement-in-cancer/)
- biomarkers: [CD38 expression](https://onco.cc/biomarkers/cd38-expression/)

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