Keytruda (pembrolizumab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Merck Canada Inc. Keytruda (pembrolizumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080285.PDF. Published April 2025. Accessed June 2025.

Regulatory approvals

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

Indication	Statements
KEYTRUDA (pembrolizumab) is indicated for the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.	2
KEYTRUDA (pembrolizumab) as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS) ≥ 1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations.	1
KEYTRUDA (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.
KEYTRUDA (pembrolizumab) is indicated Keytruda as monotherapy is indicated for the treatment of adult patients with metastatic NSCLC whose tumours express PD-L1 (TPS ≥ 1%) as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy.	1
KEYTRUDA (pembrolizumab) is indicated, as monotherapy, for the treatment of adult patients with metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by a validated test.	2
KEYTRUDA (pembrolizumab) is indicated as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.	2
KEYTRUDA (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation.
KEYTRUDA (pembrolizumab) is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression (Combined Positive Score [CPS] ≥ 1) as determined by a validated test.	1
KEYTRUDA (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy,is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test.	1
KEYTRUDA (pembrolizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.	1
KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test.	1
KEYTRUDA (pembrolizumab), in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Pembrolizumab
Sensitivity (+)	BRAF p.V600K	Melanoma	Pembrolizumab
Sensitivity (+)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Pembrolizumab
Sensitivity (+)	dMMR	Colorectal Adenocarcinoma	Pembrolizumab
Sensitivity (+)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab
Sensitivity (+)	dMMR	Any solid tumor	Pembrolizumab
Sensitivity (+)	MSI-H	Any solid tumor	Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Pembrolizumab
Sensitivity (+)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab, Trastuzumab
Sensitivity (+)	HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab
Sensitivity (+)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Paclitaxel, Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab