Regulatory approval
Published by the Health Canada.
Health Canada approved 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 gastroesophageal junction (GEJ) adenocarcinoma, whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test.
This is written in the approval document as:
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.
Citation
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 |