# Epcoritamab

Epcoritamab (Tepkinly, AbbVie Deutschland GmbH & Co. KG) has 3 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 | + lenalidomide and rituximab | 2nd line | - |
| None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |

## Products

### Tepkinly

- Company: AbbVie Deutschland GmbH & Co. KG
- Target: CD20 × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX27
- EU approval: 22 Sep 2023
- Label revised: 6 Aug 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tepkinly-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly

Mechanism (SmPC section 5.1): Epcoritamab simultaneously binds CD20 on B cells and CD3 on T cells, inducing T-cell activation and T-cell-mediated killing of CD20-expressing cancer cells.

## Label wording

- **Epcoritamab** (Tepkinly), Large B-cell lymphoma, 3rd line+: “Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf)
- **Epcoritamab** (Tepkinly), Follicular lymphoma, 2nd line: “Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf)
- **Epcoritamab** (Tepkinly), Follicular lymphoma, 3rd line+: “Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepkinly-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/epcoritamab