# Elotuzumab

Elotuzumab (Empliciti, Bristol-Myers Squibb Pharma EEIG) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + lenalidomide 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

### Empliciti

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: SLAMF7-directed monoclonal antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX08
- EU approval: 11 May 2016
- Label revised: 29 Sep 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/empliciti-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/empliciti-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/empliciti

Mechanism (SmPC section 5.1): It targets SLAMF7, directly activating natural killer cells and facilitating myeloma cell killing through antibody-dependent cellular cytotoxicity and phagocytosis.

## Label wording

- **Elotuzumab** (Empliciti), Multiple myeloma, 2nd line: “Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/empliciti-epar-product-information_en.pdf)
- **Elotuzumab** (Empliciti), Multiple myeloma, 3rd line+: “Empliciti is indicated 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 (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/empliciti-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/elotuzumab