# Glofitamab

Glofitamab (Columvi, Roche Registration GmbH ) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + gemcitabine and oxaliplatin | 2nd line | DLBCL NOS only; Ineligible for autologous stem cell transplant (ASCT) |
| None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |

## Products

### Columvi

- Company: Roche Registration GmbH 
- Target: CD20 × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX28
- EU approval: 7 Jul 2023
- Label revised: 20 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/columvi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/columvi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/columvi

Mechanism (SmPC section 5.1): Binds CD20 on B cells and CD3 on T cells to induce an immunological synapse, leading to T-cell activation and targeted lysis of CD20-expressing B cells.

## Label wording

- **Glofitamab** (Columvi), Large B-cell lymphoma, 2nd line: “Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/columvi-epar-product-information_en.pdf)
- **Glofitamab** (Columvi), Large B-cell lymphoma, 3rd line+: “Columvi 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/columvi-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/glofitamab