[A21-05] Alpelisib (breast cancer) - Addendum to Commission A20-81

Last updated 18.02.2021

Project no.:
A21-05

Commission:
Commission awarded on 12.01.2021 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Men and postmenopausal women with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy

Result of dossier assessment:

For men: added benefit still not proven; for women: now indication (instead of hint) of lesser benefit versus the comparator therapy

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)

2021.02.18 A G-BA decision was published.

G-BA documents on this decision

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