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Dossier assessment

Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-06
Last updated

Report documents

  1. Extract of dossier assessment

    Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 916 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 916 kB, EN, PDF)

  2. Dossier assessment

    Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 2 MB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 2 MB, DE, PDF)

Dossier assessment

Indication:

Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer

Result of dossier assessment:

Postmenopausal women: survival advantages, but also higher frequency of severe side effects. Overall: added benefit not proven. Pre- and perimenopausal women: indication of lesser benefit than appropriate comparator therapy for one group of patients; other groups: added benefit not proven.

Press releases

Ribociclib in advanced breast cancer: survival advantages, accompanied by severe side effects

Overall, added benefit not proven
Press release

Additional information

Federal Joint Committee (G-BA)

2019-07-04 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-06
Commission
Commission awarded on 14.01.2019 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.

Connected Projects

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  2. Dossier assessment

    Ribociclib (breast cancer; combination with aromatase inhibitors) - Benefit assessment according to §35a Social Code Book V

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    Status: Commission completed

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    Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

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  4. Dossier assessment

    Ribociclib (breast cancer; combination with an aromatase inhibitor) - Addendum to Commission A19-06

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  5. Addendum

    Ribociclib (breast cancer; combination with fulvestrant) - Addendum to Commission A19-06

    Project no.
    A19-45
    Last updated

    Status: Commission completed

  6. Dossier assessment

    Ribociclib (breast cancer, adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

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