Addendum
Acalabrutinib (pretreated chronic lymphocytic leukaemia) - Addendum to Commission A20-105
Report documents
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Addendum
Acalabrutinib (pretreated chronic lymphocytic leukaemia) - Addendum to Commission A20-105
Dossier assessment
Indication:
Adult patients with previously treated chronic lymphocytic leukaemia (CLL)
Result of dossier assessment:
Changed after addendum:
- Patients after pretreatment who have no 17p deletion or TP53 mutation and for whom chemo-immunotherapy is indicated: added benefit not proven.
- Patients after one prior therapy who have 17p deletion or TP53 mutation or for whom chemo-immunotherapy is not indicated for other reasons: hint of major added benefit.
- Patients after at least 2 pretreatments: added benefit not proven.
Additional information
Federal Joint Committee (G-BA)
2021-08-05: A G-BA decision was published.
Project details
- Project no.
- A21-54
- Commission
- Commission awarded on 27.04.2021 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
Acalabrutinib (chronic lymphocytic leukaemia; pretreated) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed