# Loncastuximab tesirine

Loncastuximab tesirine (Zynlonta, Swedish Orphan Biovitrum AB) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Large B-cell lymphoma

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

## Products

### Zynlonta

- Company: Swedish Orphan Biovitrum AB
- Target: CD19-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX22
- EU approval: 20 Dec 2022
- Label revised: 14 Sep 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zynlonta-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zynlonta-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zynlonta

Mechanism (SmPC section 5.1): Binds to CD19 on B-lineage cells, is internalised, and releases SG3199 which forms cytotoxic DNA interstrand crosslinks to induce cell death.

## Label wording

- **Loncastuximab tesirine** (Zynlonta), Large B-cell lymphoma, 3rd line+: “Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zynlonta-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/loncastuximab-tesirine