[A17-45] Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 15.12.2017

Project no.:
A17-45

Commission:
Commission awarded on 05.09.2017 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Initial endocrine therapy of HR-positive, HER2-negative, locally advanced or metastatic breast cancer in postmenopausal women

Result of dossier assessment:

Surrogate outcome "progression-free survival" not validated; side effects: indication of greater harm. Overall, there is an indication of lesser benefit versus the 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.

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

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