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Dossier assessment

Isatuximab (multiple myeloma, first line, combination with bortezomib, lenalidomide and dexamethasone) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-20
Last updated

Report documents

  1. Extract of dossier assessment

    Isatuximab (multiple myeloma, first line, combination with bortezomib, lenalidomide and dexamethasone) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 603 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-20_V1.1_en
    Download file : Extract of dossier assessment (PDF document, 603 kB, EN, not accessible)

  2. Dossier assessment

    Isatuximab (multiple myeloma, first line, combination with bortezomib, lenalidomide and dexamethasone) – 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/A25-20_V1.1
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant

Result of dossier assessment:

Hint of minor added benefit

Project details

Project no.
A25-20
Commission
Commission awarded on 11.02.2025 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.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 15.05.2025.

DOI

https://doi.org/10.60584/A25-20_V1.1_en

Connected Projects

  1. Dossier assessment

    Isatuximab (multiple myeloma after >= 2 prior therapies, combination with pomalidomide und dexamethasone) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-61
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Isatuximab (multiple myeloma after >= 1 prior therapy, combination with carfilzomib und dexamethasone) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-60
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Isatuximab (newly diagnosed multiple myeloma, eligible for stem cell transplant) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-105
    Last updated

    Status: Commission completed

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