[A25-107] Belzutifan (renal cell carcinoma) – Addendum to Project A25-45

Last updated 18.09.2025

Project no.:
A25-107

Commission:
Commission awarded on 12.08.2025 by the Federal Joint Committee (G-BA).

Report type:
Addendum

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: unchanged after addendum: hint of a minor added benefit
  • Patients ≥ 65 years of age for whom everolimus is a suitable individualized treatment: unchanged after addendum: hint of a considerable added benefit
  • Patients for whom everolimus is not a suitable individualized treatment: unchanged after addendum: added benefit not proven
Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently relevant page on the extent of the added benefit, thus completing the early benefit assessment.

DOI:

https://doi.org/10.60584/A25-107

Federal Joint Committee (G-BA)

2025-09-18 A G-BA decision was published.

G-BA documents on this decision

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