[A25-48] Ciltacabtagene autoleucel (multiple myeloma) – Addendum to Project A24-116

Last updated 15.05.2025

Project no.:
A25-48

Commission:
Commission awarded on 08.04.2025 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

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
Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

DOI:

https://doi.org/10.60584/A25-48

Federal Joint Committee (G-BA)

2025-05-15 A G-BA decision was published.

G-BA documents on this decision

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