# Polatuzumab vedotin

Polatuzumab vedotin (Polivy, Roche Registration GmbH) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + rituximab, cyclophosphamide, doxorubicin, and prednisone | 1st line | DLBCL only |
| None | + bendamustine and rituximab | 2nd line | DLBCL only; Not candidates for haematopoietic stem cell transplant |

## Products

### Polivy

- Company: Roche Registration GmbH
- Target: CD79b-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX14
- EU approval: 16 Jan 2020
- Label revised: 20 Oct 2026
- Status: orphan medicine, PRIME
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/polivy-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/polivy

Mechanism (SmPC section 5.1): Binds CD79b on B-cells, undergoes internalisation, and releases MMAE to disrupt microtubules, inhibiting cell division and inducing apoptosis.

## Label wording

- **Polatuzumab vedotin** (Polivy), Large B-cell lymphoma, 1st line: “Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf)
- **Polatuzumab vedotin** (Polivy), Large B-cell lymphoma, 2nd line: “Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/polivy-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/polatuzumab-vedotin