# Pembrolizumab

Pembrolizumab (Keytruda, Merck Sharp & Dohme B.V.) has 42 EU-approved indications in 16 tumour types. 20 need a biomarker result: PD-L1 (14) and MMR/MSI (6).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + platinum-containing chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| None | Monotherapy | Adjuvant, early | After neoadjuvant pembrolizumab + platinum-containing chemotherapy and surgical resection; High risk of recurrence |
| None | Monotherapy | Adjuvant | After complete resection and platinum-based chemotherapy; High risk of recurrence |
| None | + carboplatin and either paclitaxel or nab-paclitaxel | 1st line, metastatic | Squamous only |
| EGFR/ALK-negative | + pemetrexed and platinum chemotherapy | 1st line, metastatic | Non-squamous only |
| PD-L1 TPS ≥ 50%, EGFR/ALK-negative | Monotherapy | 1st line, metastatic | - |
| PD-L1 TPS ≥ 1% | Monotherapy | 2nd line, advanced | After at least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive |

### Mesothelioma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + pemetrexed and platinum chemotherapy | 1st line, advanced | Non-epithelioid only; Pleural mesothelioma only |

### Triple-negative breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + chemotherapy | Neoadjuvant | Then adjuvant monotherapy after surgery; Locally advanced or early-stage; high risk of recurrence |
| None | Monotherapy | Adjuvant | After neoadjuvant pembrolizumab + chemotherapy and surgical resection; Locally advanced or early-stage; high risk of recurrence |
| PD-L1 CPS ≥ 10 | + chemotherapy | 1st line, advanced | No prior chemotherapy for metastatic disease |

### Small intestine cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy |

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| MMR/MSI deficient | Monotherapy | 1st line, metastatic | - |
| MMR/MSI deficient | Monotherapy | 2nd line, advanced | After previous fluoropyrimidine-based combination therapy |

### Gastric and GEJ adenocarcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | - |
| PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | - |
| MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy |

### Oesophageal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 CPS ≥ 10 | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | - |

### Biliary tract cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + gemcitabine and cisplatin | 1st line, advanced | - |
| MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy |

### Ovarian cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 CPS ≥ 1 | + paclitaxel, with or without bevacizumab | 2nd line, advanced | After one or two prior systemic treatment regimens; platinum-resistant |

### Endometrial cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + carboplatin and paclitaxel | 1st line, advanced | Candidates for systemic therapy |
| None | + lenvatinib | Advanced | Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation |
| MMR/MSI deficient | Monotherapy | Advanced | Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation |

### Cervical cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + chemoradiotherapy (external beam radiation therapy followed by brachytherapy) | 1st line, locally advanced | No prior definitive therapy; FIGO 2014 Stage III - IVA Ambiguous in the label (line of therapy): check the SmPC. |
| PD-L1 CPS ≥ 1 | + chemotherapy with or without bevacizumab | Advanced | - |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Adjuvant | Following nephrectomy, or following nephrectomy and resection of metastatic lesions; Increased risk of recurrence |
| None | + axitinib | 1st line, advanced | - |
| None | + lenvatinib | 1st line, advanced | - |

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + enfortumab vedotin | Neoadjuvant, early | Muscle-invasive only; Then adjuvant pembrolizumab + enfortumab vedotin after surgery |
| None | + enfortumab vedotin | Adjuvant, early | Muscle-invasive only; After neoadjuvant pembrolizumab + enfortumab vedotin and radical cystectomy |
| None | + enfortumab vedotin | 1st line, advanced | - |
| None | Monotherapy | 2nd line, advanced | After prior platinum-containing chemotherapy |
| PD-L1 CPS ≥ 10 | Monotherapy | Advanced | Cisplatin-ineligible |

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Adjuvant | After complete resection; Stage IIB, IIC or III |
| None | Monotherapy | Advanced | - |

### Head and neck squamous cell carcinoma

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

### Hodgkin lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | Classical Hodgkin lymphoma only; Failed autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT is not a treatment option; Aged 3 years and older |

## Products

### Keytruda

- Company: Merck Sharp & Dohme B.V.
- Target: PD-1 inhibitor (antibody)
- Class: PD-1/PD-L1 (programmed cell death protein 1/death ligand 1) inhibitors
- ATC: L01FF02
- EU approval: 17 Jul 2015
- Label revised: 30 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/keytruda-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda

Mechanism (SmPC section 5.1): Pembrolizumab binds to the PD-1 receptor, blocking interaction with PD-L1 and PD-L2 to potentiate T-cell anti-tumour immune responses.

## Label wording

- **Pembrolizumab** (Keytruda), Melanoma, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Melanoma, adjuvant: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, neoadjuvant, early: “KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, adjuvant, early: “KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, adjuvant: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **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, 1st line, metastatic: “KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 1st line, metastatic: “KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma in adults.” [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), Mesothelioma, 1st line, advanced: “KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Hodgkin lymphoma, 3rd line+: “KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, neoadjuvant, early: “KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, adjuvant, early: “KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, 1st line, advanced: “KEYTRUDA, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, 2nd line, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior 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), 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), Renal cell carcinoma, 1st line, advanced: “KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Renal cell carcinoma, 1st line, advanced: “KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Renal cell carcinoma, adjuvant: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Colorectal cancer, 1st line, metastatic: “first-line treatment of metastatic colorectal cancer;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Colorectal cancer, 2nd line, advanced: “treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Endometrial cancer, advanced: “advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Small intestine cancer, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Biliary tract cancer, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.” [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, neoadjuvant: “KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (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, adjuvant: “KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (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), Endometrial cancer, 1st line, advanced: “KEYTRUDA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Endometrial cancer, advanced: “KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Cervical cancer, 1st line, locally advanced: “KEYTRUDA, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.” [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), Biliary tract cancer, 1st line, advanced: “KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.” [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)

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/pembrolizumab