# PD-L1

37 EU-approved indications of 11 drugs need a PD-L1 result, in 9 tumour types, most of them in non-small cell lung cancer, oesophageal cancer and head and neck squamous cell carcinoma.

## Approved indications by tumour

### Non-small cell lung cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 expression ≥ 1% | + platinum-based chemotherapy | Neoadjuvant, early | High risk of recurrence |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 expression ≥ 1% | + platinum-based chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | 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. |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 expression ≥ 1% | Monotherapy | Adjuvant, early | After neoadjuvant nivolumab + platinum-based chemotherapy and surgical resection; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 expression ≥ 50% TC or ≥ 10% IC, EGFR/ALK-negative | Monotherapy | 1st line, metastatic | - |
| [Cemiplimab](https://oncolabels.com/drugs/cemiplimab) (Libtayo) | PD-L1 TPS ≥ 1%, EGFR/ALK/ROS1-negative | + platinum-based chemotherapy | 1st line, advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
| [Cemiplimab](https://oncolabels.com/drugs/cemiplimab) (Libtayo) | PD-L1 TPS ≥ 50%, EGFR/ALK/ROS1-negative | Monotherapy | 1st line, advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 TPS ≥ 50%, EGFR/ALK-negative | Monotherapy | 1st line, metastatic | - |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 expression on ≥ 50% of tumour cells, EGFR/ALK-negative | + pemetrexed and platinum-containing chemotherapy | 1st line, advanced | Non-squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | TPS ≥ 1%, tumours express PD-L1 on ≥ 1% of tumour cells | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without progression |
| [Sugemalimab](https://oncolabels.com/drugs/sugemalimab) (Cejemly) | PD-L1 expression ≥ 1%, EGFR/ALK/ROS1-negative | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiotherapy without progression |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 TPS ≥ 1% | Monotherapy | 2nd line, advanced | After at least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive |

### Triple-negative breast cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 IC ≥ 1% | + nab-paclitaxel | 1st line, advanced | No prior chemotherapy for metastatic disease |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 10 | + chemotherapy | 1st line, advanced | No prior chemotherapy for metastatic disease |
| [Sacituzumab govitecan](https://oncolabels.com/drugs/sacituzumab-govitecan) (Trodelvy) | PD-L1 CPS ≥ 10 | + pembrolizumab | 1st line, advanced | No prior systemic therapy for metastatic disease |

### Gastric and GEJ adenocarcinoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | - |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | - |

### Oesophageal cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1st line, advanced | Squamous cell carcinoma only |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Tumour cell PD-L1 expression ≥ 1% | + fluoropyrimidine- and platinum-based combination chemotherapy | 1st line, advanced | Squamous cell carcinoma only |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1st line, advanced | Adenocarcinoma only |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Tumour cell PD-L1 expression ≥ 1% | + ipilimumab | 1st line, advanced | Squamous cell carcinoma only |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 10 | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | - |
| [Serplulimab](https://oncolabels.com/drugs/serplulimab) (Hetronifly) | PD-L1 CPS ≥ 5 | + fluoropyrimidine- and platinum-based chemotherapy | 1st line, advanced | Squamous cell carcinoma only |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 TAP score ≥ 5% | + platinum-based chemotherapy | 1st line, advanced | Squamous cell carcinoma only |

### Ovarian cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | + paclitaxel, with or without bevacizumab | 2nd line, advanced | After one or two prior systemic treatment regimens; platinum-resistant |

### Cervical cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | + chemotherapy with or without bevacizumab | Advanced | - |

### Urothelial carcinoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Tumour cell PD-L1 expression ≥ 1% | Monotherapy | Adjuvant | Muscle-invasive only; After radical resection of MIUC; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 IC ≥ 5% | Monotherapy | Advanced | Cisplatin-ineligible |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 10 | Monotherapy | Advanced | Cisplatin-ineligible |

### Melanoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Relatlimab + nivolumab](https://oncolabels.com/drugs/relatlimab-nivolumab) (Opdualag) | PD-L1 TPS < 1% | Monotherapy | 1st line, advanced | Aged 12 years and older |

### Head and neck squamous cell carcinoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | Monotherapy | Neoadjuvant, locally advanced | Then adjuvant pembrolizumab + radiation therapy with or without concomitant cisplatin, followed by monotherapy after surgery |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | + radiation therapy with or without concomitant cisplatin, followed by monotherapy | Adjuvant, locally advanced | After neoadjuvant pembrolizumab and surgical resection |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | + platinum and 5-fluorouracil (5-FU) chemotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | Monotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 TPS ≥ 50% | Monotherapy | 2nd line, advanced | Progressing on or after platinum-containing chemotherapy |

## Label wording

- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 1st line, metastatic: “KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 2nd line, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Head and neck squamous cell carcinoma, neoadjuvant, locally advanced: “KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Head and neck squamous cell carcinoma, adjuvant, locally advanced: “KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Head and neck squamous cell carcinoma, 1st line, advanced: “KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Head and neck squamous cell carcinoma, 1st line, advanced: “KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Head and neck squamous cell carcinoma, 2nd line, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Oesophageal cancer, 1st line, advanced: “KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥ 10 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Triple-negative breast cancer, 1st line, advanced: “KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Cervical cancer, advanced: “KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 1st line, advanced: “KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 1st line, advanced: “KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Ovarian cancer, 2nd line, advanced: “KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, neoadjuvant, early: “OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, neoadjuvant, early: “OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, adjuvant, early: “OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Urothelial carcinoma, adjuvant: “OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, 1st line, advanced: “OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, 1st line, advanced: “OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Gastric and GEJ adenocarcinoma, 1st line, advanced: “OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, 1st line, advanced: “OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Sugemalimab** (Cejemly), Non-small cell lung cancer, consolidation, locally advanced: “Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, consolidation, locally advanced: “IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Oesophageal cancer, 1st line, advanced: “HETRONIFLY in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Relatlimab + nivolumab** (Opdualag), Melanoma, 1st line, advanced: “Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdualag-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with pemetrexed and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Gastric and GEJ adenocarcinoma, 1st line, advanced: “Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Oesophageal cancer, 1st line, advanced: “Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 1st line, advanced: “in combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-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 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), 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)
- **Ipilimumab** (Yervoy), Oesophageal cancer, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Non-small cell lung cancer, 1st line, advanced: “LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Non-small cell lung cancer, 1st line, advanced: “LIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-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/biomarkers/pd-l1