[A25-01] Erdafitinib (urothelial carcinoma) – Benefit assessment according to §35a Social Code Book V

Last updated 01.04.2025

Project no.:
A25-01

Commission:
Commission awarded on 02.01.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Adults with unresectable or metastatic urothelial carcinoma, harbouring susceptible fibroblast growth factor receptor 3 genetic alterations after prior therapy with a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting

Result of dossier assessment:
  • and for whom cisplatin-containing chemotherapy is suitable and who have not yet received such therapy; second-line treatment: added benefit not proven
  • and for whom cisplatin-containing chemotherapy is unsuitable; second-line treatment: added benefit not proven
  • and after prior platinum-containing chemotherapy, and for whom chemotherapy is suitable; third-line treatment: added benefit not proven
Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

DOI:

https://doi.org/10.60584/A25-01

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