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Dossier assessment

Nivolumab (urothelial carcinoma, adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Status
Status: Commission completed
Project no.
A25-154
Last updated

Report documents

  1. Extract of dossier assessment

    Nivolumab (urothelial carcinoma, adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF document, 690 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-154_en
    Download file : Extract of dossier assessment (PDF document, 690 kB, EN, not accessible)

  2. Dossier assessment

    Nivolumab (urothelial carcinoma, adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF document, 4 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-154
    Download file : Dossier assessment (PDF document, 4 MB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Nivolumab (urothelial carcinoma, adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF document, 227 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 227 kB, EN, not accessible)

Dossier assessment

Indication:

Adults with muscle invasive urothelial carcinoma with tumour cell PD-L1 expression ≥ 1% and a high risk of recurrence after undergoing radical resection, for whom cisplatin-containing therapy is not suitable or who have already received neoadjuvant treatment with cisplatin; adjuvant treatment

Result of dossier assessment:
  • Male patients: hint of a minor added benefit
  • Female patients: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

05-06-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-154
Commission
Commission awarded on 15.12.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

DOI

https://doi.org/10.60584/A25-154_en

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