Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-esophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 1.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab, Trastuzumab
Sensitivity (+)	HER2-positive, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Carboplatin, Fluorouracil, Pembrolizumab, Trastuzumab