# Odronextamab

Odronextamab (Ordspono, Regeneron Ireland Designated Activity Company (DAC)) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |

## Products

### Ordspono

- Company: Regeneron Ireland Designated Activity Company (DAC)
- Target: CD20 × CD3 bispecific antibody
- EU approval: 22 Aug 2024
- Label revised: 2 Oct 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ordspono-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono

Mechanism (SmPC section 5.1): Odronextamab binds CD20 on B cells and CD3 on T cells, creating an immune synapse that induces T-cell activation and redirected lysis of CD20-expressing cells.

## Label wording

- **Odronextamab** (Ordspono), Follicular lymphoma, 3rd line+: “Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf)
- **Odronextamab** (Ordspono), Large B-cell lymphoma, 3rd line+: “Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ordspono-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/odronextamab