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Dossier assessment

Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A17-51
Last updated

Report documents

  1. Extract of dossier assessment

    Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 164 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 164 kB, EN, PDF)

  2. Dossier assessment

    Atezolizumab (urothelial carcinoma, first-line treatment) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 381 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 381 kB, DE, PDF)

Dossier assessment

Indication:

Adult patients with locally advanced or metastatic urothelial cell carcinoma, for whom cisplatin-based chemotherapy is not suitable (first-line treatment)

Result of dossier assessment:

Due to a lack of suitable data, added benefit versus chemotherapy specified by the physician not proven

Press releases

Atezolizumab, pembrolizumab, nivolumab in urothelial carcinoma: Studies of direct comparison are useful

Four dossier assessments involving comparisons between immunotherapies and chemotherapies for the same therapeutic indication in 2017 / comparison of the immunotherapies among each other missing
Press release

Additional information

Federal Joint Committee (G-BA)

2018-08-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A17-51
Commission
Commission awarded on 29.09.2017 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 (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.

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