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Dossier assessment

Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A17-40
Last updated

Report documents

  1. Extract of dossier assessment

    Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 614 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 614 kB, EN, not accessible)

  2. Dossier assessment

    Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with multiple myeloma who have received at least one previous treatment

Result of dossier assessment:

Monotherapy following progression during pretreatment: added benefit not proven. Combination with bortezomib and dexamethasone: added benefit not proven. With lenalidomide and dexamethasone: added benefit not proven for men, hints of major added benefit for women

Additional information

Federal Joint Committee (G-BA)

2018-02-15 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A17-40
Commission
Commission awarded on 15.08.2017 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 (G-BA) 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 G-BA website.

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