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Dossier assessment

Acalabrutinib (mantle cell lymphoma; combination with bendamustine and rituximab) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-89
Last updated

Report documents

  1. Extract of dossier assessment

    Acalabrutinib (mantle cell lymphoma; combination with bendamustine and rituximab) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 769 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-89_en
    Download file : Extract of dossier assessment (PDF document, 769 kB, EN, not accessible)

  2. Dossier assessment

    Acalabrutinib (mantle cell lymphoma; combination with bendamustine and rituximab) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-89
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adults with previously untreated mantle cell lymphoma who are not eligible for autologous stem cell transplant

Result of dossier assessment:
  • Patients for whom bendamustine + rituximab is a suitable individualized treatment: hint of a lesser benefit
  • Patients for whom bendamustine + rituximab is not a suitable individualized treatment: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2025-12-18 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A25-89
Commission
Commission awarded on 30.06.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

DOI

https://doi.org/10.60584/A25-89_en

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