# Mosunetuzumab

Mosunetuzumab (Lunsumio, Roche Registration GmbH) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After at least two prior systemic therapies |

## Products

### Lunsumio

- Company: Roche Registration GmbH
- Target: CD20 × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX25
- EU approval: 3 Jun 2022
- Label revised: 7 Oct 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lunsumio-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lunsumio-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio

Mechanism (SmPC section 5.1): Simultaneously engages CD20 on B-cells and CD3 on T-cells, forming an immunological synapse that activates T-cells to induce B-cell lysis via perforin and granzymes.

## Label wording

- **Mosunetuzumab** (Lunsumio), Follicular lymphoma, 3rd line+: “Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lunsumio-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/mosunetuzumab