[A19-98] Neratinib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 02.03.2020

Project no.:

Commission awarded on 29.11.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:


Extended adjuvant treatment of early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer if prior adjuvant trastuzumab-based therapy was completed less than one year ago

Result of dossier assessment:

An advantage in the outcome "recurrence" is accompanied by major disadvantages in side effects during the treatment phase; added benefit not proven


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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