# Isatuximab

Isatuximab (Sarclisa, Sanofi Winthrop Industrie) has 4 EU-approved indications in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + bortezomib, lenalidomide, and dexamethasone | 1st line | Transplant-ineligible |
| None | + bortezomib, lenalidomide, and dexamethasone | Induction | Transplant-eligible |
| None | + carfilzomib and dexamethasone | 2nd line | After at least one prior therapy |
| None | + pomalidomide and dexamethasone | 3rd line+ | After at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy |

## Products

### Sarclisa

- Company: Sanofi Winthrop Industrie
- Target: CD38-directed monoclonal antibody
- Class: CD38 (clusters of differentiation 38) inhibitors
- ATC: L01FC02
- EU approval: 30 May 2020
- Label revised: 7 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/sarclisa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa

Mechanism (SmPC section 5.1): Binds CD38 on myeloma cells to trigger tumour cell death via ADCC, ADCP, CDC, and apoptosis, while inhibiting CD38 enzymatic activity.

## Label wording

- **Isatuximab** (Sarclisa), Multiple myeloma, 3rd line+: “in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf)
- **Isatuximab** (Sarclisa), Multiple myeloma, 2nd line: “in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf)
- **Isatuximab** (Sarclisa), Multiple myeloma, 1st line: “in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf)
- **Isatuximab** (Sarclisa), Multiple myeloma, induction: “in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/isatuximab