Addendum
Alpelisib (breast cancer) - Addendum to Commission A20-81
Report documents
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Addendum
Alpelisib (breast cancer) - Addendum to Commission A20-81
Dossier assessment
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
Press releases
Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice
Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs.
Additional information
Federal Joint Committee (G-BA)
2021.02.18 A G-BA decision was published.
Project details
- Project no.
- A21-05
- Commission
- Commission awarded on 12.01.2021 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
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If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
Connected Projects
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Dossier assessment
Alpelisib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed