[A25-45] Belzutifan (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V

Last updated 01.07.2025

Project no.:
A25-45

Commission:
Commission awarded on 28.03.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Adult patients with advanced clear cell renal cell carcinoma that has progressed following 2 or more lines of therapy that included a PD‑(L)1 inhibitor and at least 2 vascular endothelial growth factor‑targeted therapies

Result of dossier assessment:
  • Patients < 65 years of age for whom everolimus is a suitable individualized treatment: hint of a minor added benefit
  • Patients ≥ 65 years of age for whom everolimus is a suitable individualized treatment: hint of a considerable added benefit
  • Patients for whom everolimus is not a suitable individualized 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/A25-45

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