Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-esophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 5. This indication is based on CA209649, a phase 3, randomized, open-label study where the choice of chemotherapy was FOLFOX (oxaliplatin, leucovorin, and fluorouracil) or CapeOX (oxaliplatin).
This is written in the approval document as:
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) >= 5.
Citation
Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised March 2024. Accessed March 22, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 5 | Esophageal Adenocarcinoma | Fluorouracil, Nivolumab, Oxaliplatin | |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 5 | Esophageal Adenocarcinoma | Nivolumab, Oxaliplatin | |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 5 | Esophagogastric Adenocarcinoma | Fluorouracil, Nivolumab, Oxaliplatin | |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 5 | Esophagogastric Adenocarcinoma | Nivolumab, Oxaliplatin | |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 5 | Adenocarcinoma of the Gastroesophageal Junction | Fluorouracil, Nivolumab, Oxaliplatin | |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 5 | Adenocarcinoma of the Gastroesophageal Junction | Nivolumab, Oxaliplatin |