# Atezolizumab

Atezolizumab (Tecentriq, Roche Registration GmbH) has 13 EU-approved indications in 5 tumour types. 6 need a biomarker result: PD-L1 (4), ALK (1) and EGFR (1).

## Approved indications

### Small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and etoposide | 1st line, advanced | - |

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 expression on ≥ 50% TC, EGFR/ALK-negative | Monotherapy | Adjuvant, early | Following complete resection and platinum-based chemotherapy; High risk of recurrence Ambiguous in the label (stage): check the SmPC. |
| EGFR/ALK-negative | + bevacizumab, paclitaxel and carboplatin | 1st line, metastatic | Non-squamous only |
| EGFR/ALK-negative | + nab-paclitaxel and carboplatin | 1st line, metastatic | Non-squamous only |
| PD-L1 expression ≥ 50% TC or ≥ 10% IC, EGFR/ALK-negative | Monotherapy | 1st line, metastatic | - |
| None | Monotherapy | 1st line, advanced | Ineligible for platinum-based therapy |
| EGFR mutation | + bevacizumab, paclitaxel and carboplatin | 2nd line, metastatic | Non-squamous only; After failure of appropriate targeted therapies |
| ALK fusion | + bevacizumab, paclitaxel and carboplatin | 2nd line, metastatic | Non-squamous only; After failure of appropriate targeted therapies |
| None | Monotherapy | 2nd line, advanced | After prior chemotherapy; patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies |

### Triple-negative breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 IC ≥ 1% | + nab-paclitaxel | 1st line, advanced | No prior chemotherapy for metastatic disease |

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + bevacizumab | 1st line, advanced | No prior systemic therapy |

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | After prior platinum-containing chemotherapy |
| PD-L1 IC ≥ 5% | Monotherapy | Advanced | Cisplatin-ineligible |

## Products

### Tecentriq

- Company: Roche Registration GmbH
- Target: PD-L1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF05
- EU approval: 20 Sep 2017
- Label revised: 21 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tecentriq-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tecentriq

Mechanism (SmPC section 5.1): Atezolizumab binds directly to PD-L1, blocking its interaction with PD-1 and B7.1 receptors to relieve immune suppression and reactivate the antitumor immune response.

## Label wording

- **Atezolizumab** (Tecentriq), Urothelial carcinoma, 2nd line, advanced: “Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC:
 after prior platinum-containing chemotherapy, or” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Urothelial carcinoma, advanced: “who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, adjuvant, early: “Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, metastatic: “In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, metastatic: “In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥ 50% TC or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, advanced: “Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, advanced: “Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Small cell lung cancer, 1st line, advanced: “Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Triple-negative breast cancer, 1st line, advanced: “Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Hepatocellular carcinoma, 1st line, advanced: “Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-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/atezolizumab