# Obinutuzumab

Obinutuzumab (Gazyvaro, Roche Registration GmbH) has 5 EU-approved indications in 2 tumour types.

## Approved indications

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + chlorambucil | 1st line | Comorbidities making them unsuitable for full-dose fludarabine based therapy |

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + chemotherapy | 1st line, advanced | Then maintenance monotherapy |
| None | Monotherapy | Maintenance, advanced | After Gazyvaro in combination with chemotherapy achieving a response |
| None | Monotherapy | Maintenance | After Gazyvaro in combination with bendamustine without progression; did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen |
| None | + bendamustine | 2nd line | Then maintenance monotherapy; Did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen |

## Products

### Gazyvaro

- Company: Roche Registration GmbH
- Target: Anti-CD20 monoclonal antibody
- Class: CD20 (clusters of differentiation 20) inhibitors
- ATC: L01FA03
- EU approval: 22 Jul 2014
- Label revised: 17 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/gazyvaro-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/gazyvaro

Mechanism (SmPC section 5.1): Binds to CD20 on B-lymphocytes to induce direct cell death and mediate enhanced ADCC and ADCP via FcγRIII-bearing effector cells, leading to potent B-cell depletion.

## Label wording

- **Obinutuzumab** (Gazyvaro), Chronic lymphocytic leukaemia, 1st line: “Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, 1st line, advanced: “Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, maintenance, advanced: “Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, 2nd line: “Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, maintenance: “Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-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/obinutuzumab