Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab as a monotherapy treatment option for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC, providing patients are unsuitable for adjuvant treatment with platinum based chemotherapy.
This is written in the approval document as:
As monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC, providing patients are unsuitable for adjuvant treatment with platinum based chemotherapy.
Reimbursement
ODMS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | PD-L1 >= 1% | Bladder Urothelial Carcinoma | Nivolumab |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-12-01 | Health Service Executive | Indication approved for reimbursement. |
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |