Daratumumab (12) – Darzalex®
Multiple myeloma, first-line, stem cell transplantation suitable, combination with bortezomib, lenalidomide and dexamethasone
Characteristics
| Start date | 01.12.2024 – Marketing authorisation: 21.10.2024 |
|---|---|
| Resolution | 15.05.2025 |
| INN | Daratumumab |
| Brand name | Darzalex® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-1138 |
| ATC code | L01FC01 CD38 inhibitors (L01FC) |
| ICD-10 codes (AIS) | C90.00Multiple myeloma with failed remission, C90.01Multiple myeloma in remission |
| Alpha-ID codes (AIS) | I21328Multiple myeloma, I31059Multiple myeloma in complete remission |
| ORPHAcodes (AIS) | 29073Multiple myeloma, |
| Therapeutic area | Oncological diseases Multiple myeloma (MM) Orphan (turnover limit) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Darzalex is indicated in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with newly diagnosed multiple myeloma who are suitable for autologous stem cell transplantation | An induction therapy consisting of: - bortezomib + thalidomide + dexamethasone (VTd) or - bortezomib + cyclophosphamide + dexamethasone (VCd) [only for patients with peripheral polyneuropathy or an increased risk of developing peripheral polyneuropathy; cf. Annex VI to Section K of the medicines directive (AM-RL)] or - daratumumab + bortezomib + thalidomide + dexamethasone (D-VTd) - followed by high-dose therapy with melphalan and subsequent autologous stem cell transplantation - followed by consolidation therapy with D-VTd (only if induction therapy with D-VTd is used) - followed by maintenance therapy consisting of: Lenalidomide |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PERSEUS) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- To assess the additional benefit of daratumumab in combination with bortezomib, lenalidomide and dexamethasone compared with the appropriate comparator therapy, the pharmaceutical manufacturer submitted the ongoing, open-label, randomised PERSEUS trial.
Adults with newly diagnosed multiple myeloma who are suitable for autologous stem cell transplantation
- The additional benefit is not proven.
- Overall, the induction and consolidation therapy with VRd administered in the control arm of the PERSEUS trial does not correspond to the appropriate comparator therapy as defined by the G-BA. Consequently, the appropriate comparator therapy has not been implemented in the PERSEUS trial. Consequently, the PERSEUS study is not suitable for assessing the additional benefit of daratumumab + bortezomib + lenalidomide + dexamethasone compared with the appropriate comparator therapy.
- Consequently, there are no suitable data available to enable an assessment of the additional benefit, which is why an additional benefit of daratumumab in combination with bortezomib, lenalidomide and dexamethasone in the treatment of patients with newly diagnosed multiple myeloma, who are suitable for autologous stem cell transplantation, proof that they are suitable has not been proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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