[A20-58] Ribociclib (breast cancer, combination with fulvestrant) - Addendum to commission A20-22

Last updated 20.08.2020

Project no.:
A20-58

Commission:
Commission awarded on 06.07.2020 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

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

Result of dossier assessment:

Conclusion of dossier assessment A20-22 unchanged: for patients with initial endocrine therapy, indication of minor added benefit; for patients who have already received prior endocrine therapy, added benefit not proven.

Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

Federal Joint Committee (G-BA)

2020-08-20: A G-BA decision was published.

G-BA documents on this decision

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