Regulatory approval
Published by the Health Service Executive. Approved
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.
This is written in the approval document.
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 |