[A18-41] Pertuzumab (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 01.10.2018

Project no.:
A18-41

Commission:
Commission awarded on 21.06.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

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

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.

01.10.2018

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

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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