# Tafasitamab

Tafasitamab (Minjuvi, Incyte Biosciences Distribution B.V.) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + lenalidomide followed by monotherapy | 2nd line | DLBCL only; Not eligible for autologous stem cell transplant (ASCT) |

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + lenalidomide and rituximab | 2nd line | After at least one line of systemic therapy; Grade 1-3a |

## Products

### Minjuvi

- Company: Incyte Biosciences Distribution B.V.
- Target: CD19-directed monoclonal antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX12
- EU approval: 26 Aug 2021
- Label revised: 27 Jan 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/minjuvi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/minjuvi

Mechanism (SmPC section 5.1): Binds CD19 on B lymphocytes to mediate B-cell lysis through immune effector cell engagement (enhanced ADCC and ADCP) and direct induction of apoptosis.

## Label wording

- **Tafasitamab** (Minjuvi), Large B-cell lymphoma, 2nd line: “MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdf)
- **Tafasitamab** (Minjuvi), Follicular lymphoma, 2nd line: “MINJUVI is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/minjuvi-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/tafasitamab