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[A25-40] Daratumumab (systemic light chain amyloidosis) – Benefit assessment according to §35a Social Code Book V

Last updated 02.06.2025

Project no.:
A25-40

Commission:
Commission awarded on 28.02.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Immune system and infections

Indication:

Adults with newly diagnosed systemic AL amyloidosis for whom bortezomib in combination with cyclophosphamide and dexamethasone is the suitable therapy for the individual patient

Result of dossier assessment:

Hint of considerable added benefit

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.

DOI:

https://doi.org/10.60584/A25-40

Project no. Title Status
A24-114 Daratumumab (newly diagnosed multiple myeloma, suitable for autologous stem cell transplant) – Benefit assessment according to §35a Social Code Book V Commission completed
A23-127 Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V Commission completed
A22-40 Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) Commission completed
A21-126 Daratumumab (newly diagnosed multiple myeloma, unsuitable for stem cell transplantation) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Commission completed
A21-101 Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V Commission completed
A21-100 Daratumumab (systemic light chain amyloidosis) - Benefit assessment according to §35a Social Code Book V Commission completed
A20-14 Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V Commission completed
A20-15 Daratumumab (multiple myeloma, stem cell transplant) - Benefit assessment according to §35a Social Code Book V Commission completed
A18-66 Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V Commission completed
A17-40 Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V Commission completed
G16-02 Daratumumab - Assessment according to §35a (para. 1., sentence 10) Social Code Book V Commission completed

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