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Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-41
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 171 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 171 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence, in combination with trastuzumab and chemotherapy

Result of dossier assessment:

Patients < 65 years: added benefit not proven; patients ≥ 65 years: hint of lesser benefit in comparison with the appropriate comparator therapy

Press releases

Pertuzumab in early breast cancer: no added benefit proven despite exemplary surrogate validation

Effect on disease-free survival too small to draw a conclusion for overall survival
Press release

Additional information

Federal Joint Committee (G-BA)

2018-12-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-41
Commission
Commission awarded on 21.06.2018 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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  5. Addendum

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  7. Dossier assessment

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