Elranatamab (1) – Elrexfio®
Multiple myeloma, relapsed and refractory, after at least 3 previous therapies
Characteristics
| Start date | 15.01.2024 – Marketing authorisation: 07.12.2023 |
|---|---|
| Resolution | 04.07.2024 |
| INN | Elranatamab |
| Brand name | Elrexfio® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-1033 |
| ATC code | n.d. |
| 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 |
| Therapeutic area | Oncological diseases Multiple myeloma (MM) |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
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Elrexfio is used as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have previously received at least three therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with relapsed and refractory multiple myeloma who have received three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last therapy | Patient-specific therapy with selection of – Carfilzomib in combination with lenalidomide and dexamethasone – Elotuzumab in combination with lenalidomide and dexamethasone – Elotuzumab in combination with pomalidomide and dexamethasone – Daratumumab in combination with bortezomib and dexamethasone – Daratumumab in combination with lenalidomide and dexamethasone – Daratumumab in combination with carfilzomib and dexamethasone – Daratumumab in combination with pomalidomide and dexamethasone (only for people who are refractory to lenalidomide) – Isatuximab in combination with carfilzomib and dexamethasone – Isatuximab in combination with pomalidomide and dexamethasone – Pomalidomide in combination with bortezomib and dexamethasone (only for people who are refractory to an anti-CD38 antibody and lenalidomide) – Ixazomib in combination with lenalidomide and dexamethasone (only for people who are refractory to bortezomib, carfilzomib and an anti-CD38 antibody) – Carfilzomib in combination with dexamethasone, taking into account the active substances and combinations of active substances used in the previous therapies and the type and duration of response to the respective previous therapies |
| b) | Adults with relapsed and refractory multiple myeloma who have received at least 4 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last therapy | A patient-specific therapy with the selection of – Carfilzomib in combination with lenalidomide and dexamethasone – Elotuzumab in combination with lenalidomide and dexamethasone – Elotuzumab in combination with pomalidomide and dexamethasone – Daratumumab in combination with bortezomib and dexamethasone – Daratumumab in combination with lenalidomide and dexamethasone – Daratumumab in combination with carfilzomib and dexamethasone – Daratumumab in combination with pomalidomide and dexamethasone – Isatuximab in combination with carfilzomib and dexamethasone – Isatuximab in combination with pomalidomide and dexamethasone – Pomalidomide in combination with bortezomib and dexamethasone (only for people who are refractory to an anti-CD38 antibody and lenalidomide) – Ixazomib in combination with lenalidomide and dexamethasone (only for people who are refractory to bortezomib, carfilzomib and an anti-CD38 antibody) – Panobinostat in combination with bortezomib and dexamethasone – Carfilzomib in combination with dexamethasone – Pomalidomide in combination with dexamethasone (only for at least double-refractory patients who are not suitable for triplet therapy) – Lenalidomide in combination with dexamethasone (only for at least double-refractory patients who are not suitable for triplet therapy) – Bortezomib in combination with pegylated liposomal doxorubicin (only for at least double-refractory patients who are not suitable for triplet therapy) – Bortezomib in combination with dexamethasone (only for at least double-refractory patients who are not suitable for triplet therapy) – Daratumumab monotherapy (only for at least triple refractory patients who are not suitable for triplet or doublet therapy) – Cyclophosphamide as monotherapy or in combination with dexamethasone (only for at least triple refractory patients who are not suitable for triplet or doublet therapy) – Melphalan as monotherapy or in combination with prednisolone or prednisone (only for at least triple refractory patients who are not suitable for triplet or doublet therapy), taking into account the general condition, the active substances and combinations of active substances used in the previous therapies and the type and duration of response to the respective previous therapies |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (MagnetisMM-3) 0 (Data not accepted) |
|---|---|
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Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + historical comparison) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
| ACT change | 15.05.2024 – Änderung der Therapiestandards |
- Clinical trials
- The MagnetisMM-3 trial is an open-label, single-arm PhaseII trial designed to investigate the safety and efficacy of elranatamab for the treatment of adults with relapsed or refractory multiple myeloma whose previous lines of treatment included an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody.
a) Adults with relapsed and refractory multiple myeloma who have received three prior lines of treatment, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last line of treatment
- An additional benefit is not proven.
- Overall, due to its single-arm design, the MagnetisMM-3 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of elranatamab compared with the appropriate comparator therapy.
- Overall assessment
- The results of the single-arm MagnetisMM-3 study are available for the assessment of the additional benefit of elranatamab. These are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy. Consequently, there is no evidence of any additional benefit of elranatamab as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma who have previously received at least three lines of therapy, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment, proof of this has not been established.
b) Adults with relapsed and refractory multiple myeloma who have received at least four prior treatments, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent course of treatment
- The additional benefit is not proven.
- Overall, due to its single-arm design, the MagnetisMM-3 study submitted by the pharmaceutical manufacturer does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of elranatamab compared with the appropriate comparator therapy.
- Overall assessment
- The results of the single-arm MagnetisMM-3 study are available for the assessment of the additional benefit of elranatamab. These are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy. Consequently, there is no evidence of any additional benefit of elranatamab as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma who have previously received at least three lines of therapy, including an immunomodulatory active ingredient (INN), a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment, proof of this has not been provided.
Courtesy translation only, please refer to the German original.
Associated procedures
| Elranatamab (1) | Elrexfio® | Pfizer Pharma GmbH | Multiple myeloma, relapsed and refractory, after at least 3 previous therapies | 1,250–1,340 | 100% additional benefit not proven |
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