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Dossier assessment

Ipilimumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-12
Last updated

Report documents

  1. Extract of dossier assessment

    Ipilimumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 520 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 520 kB, EN, not accessible)

  2. Dossier assessment

    Ipilimumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 958 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 958 kB, DE, not accessible)

Dossier assessment

Indication:

Treatment-naive adults with intermediate/poor-risk advanced renal cell carcinoma

Result of dossier assessment:

Indication of considerable added benefit for intermediate risk profile; indication of major added benefit for poor risk profile

Press releases

Nivolumab with ipilimumab: drug combination has added benefit in advanced renal cell carcinoma

Advantages in overall survival are not offset by serious disadvantages
Press release

Additional information

Federal Joint Committee (G-BA)

2019-08-15 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-12
Commission
Commission awarded on 04.02.2019 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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