PD-L1 in urothelial carcinoma
3 EU-approved indications in urothelial carcinoma need a PD-L1 result: pembrolizumab (advanced), nivolumab (adjuvant) and atezolizumab (advanced).
Muscle invasion
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| PD-L13 | ||||
Opdivo | Tumour cell PD-L1 expression ≥ 1% | Monotherapy | Adj. | Muscle-invasive only; After radical resection of MIUC; High risk of recurrence |
Tecentriq | IC ≥ 5% | Monotherapy | Any line advanced | Cisplatin-ineligible |
Keytruda | CPS ≥ 10 | Monotherapy | Any line advanced | Cisplatin-ineligible |
16 approvals for Urothelial need no biomarker and apply whatever the result. All approvals for Urothelial
See also
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated 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 (see section 5.1).
- Atezolizumab (Tecentriq)
who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).