Urothelial carcinoma
The EU has approved 20 indications of 9 drugs in urothelial carcinoma. 4 of them need a biomarker result: PD-L1 (3) and FGFR (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Muscle invasion
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| FGFR3 alteration1 | ||||
Balversa | Susceptible FGFR3 genetic alterations | Monotherapy | 2L advanced | After at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting |
| 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 |
| No biomarker required16 | ||||
Imfinzi | None | + gemcitabine and cisplatin | Neoadj. early | Muscle-invasive only; Then adjuvant monotherapy after surgery |
Padcev | None | + pembrolizumab | Neoadj. early | Muscle-invasive only; Then adjuvant enfortumab vedotin + pembrolizumab after surgery |
Keytruda | None | + enfortumab vedotin | Neoadj. early | Muscle-invasive only; Then adjuvant pembrolizumab + enfortumab vedotin after surgery |
Imfinzi | None | Monotherapy | Adj. early | Muscle-invasive only; After neoadjuvant durvalumab + gemcitabine and cisplatin and radical cystectomy |
Padcev | None | + pembrolizumab | Adj. early | Muscle-invasive only; After neoadjuvant enfortumab vedotin + pembrolizumab and radical cystectomy |
Keytruda | None | + enfortumab vedotin | Adj. early | Muscle-invasive only; After neoadjuvant pembrolizumab + enfortumab vedotin and radical cystectomy |
Padcev | None | + pembrolizumab | 1L advanced | Eligible for platinum-containing chemotherapy |
Opdivo | None | + cisplatin and gemcitabine | 1L advanced | None |
Keytruda | None | + enfortumab vedotin | 1L advanced | None |
Bavencio | None | Monotherapy | Maint. advanced | Progression-free following platinum-based chemotherapy |
Tecentriq | None | Monotherapy | 2L advanced | After prior platinum-containing chemotherapy |
Padcev | None | Monotherapy | 2L advanced | Previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor |
Opdivo | None | Monotherapy | 2L advanced | After failure of prior platinum-containing therapy |
Keytruda | None | Monotherapy | 2L advanced | After prior platinum-containing chemotherapy |
Adstiladrinconditional | None | Monotherapy | Any line early | Non-muscle-invasive only; BCG-unresponsive; carcinoma in situ (CIS) with or without papillary tumours |
Anktivaconditional | None | + Bacillus Calmette-Guérin (BCG) | Any line early | Non-muscle-invasive with carcinoma in situ only; BCG-unresponsive; with or without papillary tumours |
Tumour-agnostic approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
Rozlytrekconditional | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Augtyroconditional | Monotherapy | Any line advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older | |
| RET fusion1 | ||||
Retsevmo | Monotherapy | Any line advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older | |
Biomarkers in urothelial carcinoma
Label wording20
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
- 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).
- Nivolumab (Opdivo)
OPDIVO in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
- Avelumab (Bavencio)
Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.
- Enfortumab vedotin (Padcev)
Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).
- Enfortumab vedotin (Padcev)
Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).
- Enfortumab vedotin (Padcev)
Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.
- Enfortumab vedotin (Padcev)
Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor (see section 5.1).
- Durvalumab (Imfinzi)
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
- Durvalumab (Imfinzi)
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
- Atezolizumab (Tecentriq)
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC: after prior platinum-containing chemotherapy, or
- Atezolizumab (Tecentriq)
who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).
- Erdafitinib (Balversa)
Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).
- Nadofaragene firadenovec (Adstiladrin)
ADSTILADRIN is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
- Nogapendekin alfa inbakicept (Anktiva)
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.