Dossier assessment

Ciltacabtagene autoleucel (multiple myeloma, at least one prior therapy) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-116
Last updated

Report documents

  1. Extract of dossier assessment

    Ciltacabtagene autoleucel (multiple myeloma, at least one prior therapy) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 843 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-116_en
  2. Dossier assessment

    Ciltacabtagene autoleucel (multiple myeloma, at least one prior therapy) – 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/A24-116

Dossier assessment

Indication:

Adults with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide

Result of dossier assessment:
  • Patients with 1 to 3 prior therapies for whom daratumumab in combination with pomalidomide and dexamethasone (DPd) or pomalidomide in combination with bortezomib and dexamethasone (PVd) is a suitable individualized therapy: hint of a non-quantifiable added benefit
  • Patients with 1 to 3 prior therapies for whom DPd or PVd is not a suitable individualized therapy, and patients with ≥ 4 prior therapies: added benefit not proven

Project details

Project no.
A24-116
Commission
Commission awarded on 29.11.2024 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/A24-116_en

Connected Projects

  1. Dossier assessment

    Ciltacabtagene autoleucel (multiple myeloma) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V

    Project no.
    G23-04
    Last updated

    Status: Commission completed

  2. Addendum

    Ciltacabtagene autoleucel (multiple myeloma) – Addendum to Project A24-116

    Project no.
    A25-48
    Last updated

    Status: Commission completed

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