Regulatory approval
Published by the Health Canada. Approved
Health Canada approved nivolumab, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression >= 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC.
This is written in the approval document as:
OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression >= 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HC (1) | PD-L1 >= 1% | Esophageal Squamous Cell Carcinoma | Cisplatin, Fluorouracil, Nivolumab | |
| HC (1) | PD-L1 >= 1% | Esophageal Squamous Cell Carcinoma | Fluorouracil, Nivolumab, Oxaliplatin |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |