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

Last updated 15.12.2017

Project no.:

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

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:


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


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.


Info Service

Subscribe to daily updated information on projects, calls for tender, and events as well as our press releases.

Contact form

Questions about commissions, publications and press releases can be sent to us via this form.