Keytruda (pembrolizumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s178lbl.pdf. Revised July 2025. Accessed September 2, 2025.

Regulatory approvals

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

Indication	Statements
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) >=1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.	1
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS >=1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.	1
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test.	1
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS >=10) as determined by an FDA-approved test.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.	8
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.	1
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.	1
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.	1
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test.	2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >= 1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT), with or without cisplatin and then as a single agent.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Pembrolizumab, Pemetrexed
FDA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Pembrolizumab, Pemetrexed
FDA (1)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
FDA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Pembrolizumab
FDA (1)	dMMR	Any solid tumor	Pembrolizumab
FDA (1)	MSI-H	Any solid tumor	Pembrolizumab
FDA (1)	dMMR	Colorectal Adenocarcinoma	Pembrolizumab
FDA (1)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab
FDA (1)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab, Trastuzumab
FDA (1)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Pembrolizumab, Trastuzumab
FDA (1)	HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab
FDA (1)	HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 10	Adenocarcinoma of the Gastroesophageal Junction	Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Cisplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Cisplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Carboplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Carboplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Pembrolizumab
FDA (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Pembrolizumab
FDA (1)	MSI-L	Endometrial Carcinoma	Lenvatinib, Pembrolizumab
FDA (1)	pMMR	Endometrial Carcinoma	Pembrolizumab
FDA (1)	MSI-H	Endometrial Carcinoma	Pembrolizumab
FDA (1)	TMB-H (>= 10 mutations / Mb)	Any solid tumor	Pembrolizumab
FDA (1)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab
FDA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Paclitaxel, Pembrolizumab
FDA (1)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Carboplatin, Gemcitabine, Pembrolizumab