Erdafitinib (1) – Balversa®
Urothelial carcinoma, FGFR3 alterations, pretreated with PD-(L)1 inhibitor
Characteristics
| Start date | 01.01.2025 – Marketing authorisation: 22.08.2024 |
|---|---|
| Resolution | 18.06.2025 |
| INN | Erdafitinib |
| Brand name | Balversa® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-1150 |
| ATC code | L01EN01 FGFR tyrosine kinase inhibitors (L01EN) |
| ICD-10 codes (AIS) | C65Malignant neoplasm of renal pelvis, C66Malignant neoplasm of ureter, C67.0Malignant neoplasm of trigone of bladder, C67.1Malignant neoplasm of dome of bladder, C67.2Malignant neoplasm of lateral wall of bladder, C67.3Malignant neoplasm of anterior wall of bladder, C67.4Malignant neoplasm of posterior wall of bladder, C67.5Malignant neoplasm of internal urethral orifice, C67.6Malignant neoplasm of ureteric orifice, C67.7Malignant neoplasm of urachus, C67.8Malignant neoplasm of overlapping sites of bladder, C67.9Malignant neoplasm of bladder, unspecified, C68.0Malignant neoplasm of urethra, C68.8Primary malignant neoplasm of two or more contiguous sites of urinary organs whose point of origin cannot be determined, C68.9Malignant neoplasm of urinary system NOS |
| Alpha-ID codes (AIS) | I133924Malignant neoplasm of the urinary bladder, overlapping several parts, I13895Malignant neoplasm of the urinary bladder, I14845Malignant neoplasm of the neck of the bladder, I15288Malignant neoplasm of the posterior bladder wall, I15360Malignant neoplasm of the lateral bladder wall, I15411Malignant neoplasm of the anterior bladder wall, I20177Malignant neoplasm of the renal pelvis, I20685Malignant neoplasm of the ostium ureteris, I22423Malignant neoplasm of the trigonum vesicae, I22501Malignant neoplasm of the urachus, I22610Malignant neoplasm of the ureter, I22762Malignant neoplasm of the urethra, I22909Urothelial carcinoma, I30262Malignant neoplasm of the apex vesicae |
| Therapeutic area | Oncological diseases Urothelial carcinoma (UC) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC) and certain genetic alterations of fibroblast growth factor receptor 3 (FGFR3) who have previously received at least one line of therapy with a PD-1 or PD-L1 inhibitor in the unresectable or metastatic stage. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a1) | Adults with unresectable or metastatic urothelial carcinoma with certain genetic alterations of FGFR3, after prior therapy with a PD-1 or PD-L1 inhibitor in the unresectable or metastatic stage, and who are eligible for and have not yet received cisplatin-containing chemotherapy; second-line treatment | Cisplatin in combination with gemcitabine |
| a2) | Adults with unresectable or metastatic urothelial carcinoma with certain genetic alterations of FGFR3, after prior therapy with a PD-1 or PD-L1 inhibitor in the unresectable or metastatic stage, and who are not suitable for cisplatin-containing chemotherapy; second-line treatment | - Vinflunine or - docetaxel or - paclitaxel |
| b) | Adults with unresectable or metastatic urothelial carcinoma with certain genetic alterations of FGFR3, after prior treatment with platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor in the unresectable or metastatic stage, and who are suitable for chemotherapy; third-line treatment | Enfortumab Vedotin |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (THOR) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
a1) Adults with unresectable or metastatic urothelial carcinoma exhibiting specific genetic alterations in FGFR3, following prior treatment with a PD-1 or PD-L1 inhibitor at the unresectable or metastatic stage, and who are suitable for cisplatin-containing chemotherapy and have not yet received it; second-line treatment
- An additional benefit is not proven.
- The data from the THOR study are not suitable for assessing additional benefit. In the control arm of Cohort 1, patients were treated with chemotherapy (vinflunine or docetaxel). This does not correspond to the appropriate comparator therapies for patient groups a1 and b. There are therefore no suitable data available for an assessment of the additional benefit of erdafitinib.
a2) Adults with unresectable or metastatic urothelial carcinoma exhibiting specific genetic alterations in FGFR3, following prior treatment with a PD-1 or PD-L1 inhibitor at the unresectable or metastatic stage, and who are not suitable for cisplatin-containing chemotherapy; second-line treatment
- The additional benefit is not proven.
- The active ingredients vinflunine and docetaxel, used in the comparator arm of Cohort 1, represent – alongside paclitaxel – the appropriate comparator therapy for the patient population. However, not all patients in Cohort 1 represent the patient population a2.
- Irrespective of this, the exact proportion of patients who were treated in accordance with the appropriate comparator therapy cannot be determined on the basis of the data provided.
- As part of the commenting procedure, the pharmaceutical manufacturer submitted, amongst other things, analyses of the total population of Cohort 1. However, these do not allow any conclusions to be drawn regarding patient population a2, as not all patients in Cohort 1 represent patient population a2. There are therefore no suitable data available for an assessment of the additional benefit of erdafitinib.
b) Adults with unresectable or metastatic urothelial carcinoma exhibiting specific genetic alterations in FGFR3, following prior treatment with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor at the unresectable or metastatic stage, and who are suitable for chemotherapy; third-line treatment
- The additional benefit is not proven.
- The data from the THOR study are not suitable for assessing additional benefit. In the control arm of Cohort 1, patients were treated with chemotherapy (vinflunine or docetaxel). This does not correspond to the appropriate comparator therapies for patient groups a1 and b. There are therefore no suitable data available for an assessment of the additional benefit of erdafitinib.
Courtesy translation only, please refer to the German original.
Associated procedures
| Erdafitinib (1) | Balversa® | Janssen-Cilag GmbH | Urothelial carcinoma, FGFR3 alterations, pretreated with PD-(L)1 inhibitor | 169–207 | 100% additional benefit not proven |
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