Keytruda (pembrolizumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
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.	5
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.	1
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.	1
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.	3
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.	1
KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: first-line treatment of metastatic colorectal cancer; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine -based combination therapy.	2
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with 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.	2
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.	6
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.	2
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.	1
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.	3
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.	2
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.	2
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Pembrolizumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Pembrolizumab, Pemetrexed
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Pembrolizumab
EMA (1)	dMMR	Colorectal Adenocarcinoma	Pembrolizumab
EMA (1)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab
EMA (1)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab, Trastuzumab
EMA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Carboplatin, Paclitaxel, Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab
EMA (1)	MSI-H	Endometrial Carcinoma	Pembrolizumab
EMA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Paclitaxel, Pembrolizumab
EMA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Carboplatin, Gemcitabine, Pembrolizumab
EMA (1)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
EMA (1)	CD274 amplification, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Pembrolizumab
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Gemcitabine, Pembrolizumab
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Paclitaxel, Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 10	Bladder Urothelial Carcinoma	Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Carboplatin, Fluorouracil, Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Pembrolizumab
EMA (1)	PD-L1 >= 50%	Head and Neck Squamous Cell Carcinoma	Pembrolizumab
EMA (1)	dMMR	Endometrial Carcinoma	Pembrolizumab
EMA (1)	MSI-H	Esophagogastric Adenocarcinoma	Pembrolizumab
EMA (1)	dMMR	Esophagogastric Adenocarcinoma	Pembrolizumab
EMA (1)	MSI-H	Gastrointestinal Stromal Tumor	Pembrolizumab
EMA (1)	dMMR	Gastrointestinal Stromal Tumor	Pembrolizumab
EMA (1)	MSI-H	Cholangiocarcinoma	Pembrolizumab
EMA (1)	dMMR	Cholangiocarcinoma	Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Cisplatin, Fluorouracil, Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Carboplatin, Fluorouracil, Pembrolizumab
EMA (1)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Pembrolizumab
EMA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Nab-paclitaxel, Pembrolizumab
EMA (1)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Carboplatin, Fluorouracil, Pembrolizumab, Trastuzumab
EMA (1)	HER2-negative, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab
EMA (1)	HER2-negative, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Carboplatin, Fluorouracil, Pembrolizumab