Addendum
Ciltacabtagene autoleucel (multiple myeloma) – Addendum to Project A24-116
Report documents
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Addendum
Ciltacabtagene autoleucel (multiple myeloma) – Addendum to Project 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 treatment:
After addendum now: hint of considerable added benefit - Patients with 1 to 3 prior therapies for whom DPd or PVd is not a suitable individualized treatment, and patients with ≥ 4 prior therapies: added benefit not proven
Unchanged after addendum: added benefit not proven
Additional information
Federal Joint Committee (G-BA)
2025-05-15 A G-BA decision was published.
Project details
- Project no.
- A25-48
- Commission
- Commission awarded on 08.04.2025 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
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If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
- DOI
https://doi.org/10.60584/A25-48_en
Connected Projects
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Dossier assessment
Ciltacabtagene autoleucel (multiple myeloma, at least one prior therapy) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed