Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
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