Teclistamab (1) – Tecvayli®
Multiple myeloma, at least 3 prior therapies
Characteristics
| Start date | 01.09.2023 – Marketing authorisation: 23.08.2022 |
|---|---|
| Resolution | 15.02.2024 |
| Limitation date | 01.01.2027 |
| INN | Teclistamab |
| Brand name | Tecvayli® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-978 |
| ATC code | L01FX24 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| 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 |
| Therapeutic indication of the resolution |
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Tecvayli 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 |
|---|---|---|
| Adults with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulator, a proteasome proteasome inhibitor and an anti-CD38 antibody, and have shown disease progression under the last disease progression under the last therapy | A patient-individualised therapy with a choice of: – Bortezomib monotherapy – Bortezomib + pegylated liposomal doxorubicin – bortezomib + dexamethasone – Carfilzomib + lenalidomide and dexamethasone – Carfilzomib + dexamethasone – Daratumumab + lenalidomide + dexamethasone – Daratumumab + bortezomib + dexamethasone – Daratumumab monotherapy – Daratumumab + pomalidomide + dexamethasone – Elotuzumab + lenalidomide + dexamethasone – Elotuzumab + pomalidomide + dexamethasone – Isatuximab + pomalidomide + dexamethasone – Ixazomib + lenalidomide + dexamethasone – Lenalidomide + dexamethasone – Panobinostat + bortezomib and dexamethasone – Pomalidomide + bortezomib and dexamethasone – Pomalidomide + dexamethasone – Cyclophosphamide in combination with other antineoplastic drugs – Melphalan as monotherapy or in combination with prednisolone or prednisone – Doxorubicin as monotherapy or in combination with other antineoplastic drugs – Vincristine in combination with other antineoplastic drugs – Dexamethasone in combination with other antineoplastic drugs – Prednisolone in combination with other antineoplastic drugs – Prednisone in combination with other antineoplastic drugs – Best supportive care taking into account previous therapies and the severity and duration of the response |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (MajesTEC-1) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Uncontrolled study) |
- Clinical trials
- The MajesTEC-1 trial is an open-label, single-arm Phase I/IIstudy investigating the safety and efficacy of teclistamab for the treatment of adults with relapsed or refractory multiple myeloma whose previous lines of therapy included an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody.
Adults with relapsed and refractory multiple myeloma who have received at least three prior lines of treatment, including an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during their most recent treatment
- There is therefore no evidence of additional benefit from teclistamab as monotherapy in adults with relapsed and refractory multiple myeloma who have received at least three prior lines of treatment, including an immunomodulator, a proteasome inhibitor and an anti-CD38antibody, and who have shown disease progression during their most recent treatment, is not proven.
- The data submitted are not suitable for a comparison with the appropriate comparator therapy.
- Overall assessment
- The results of the single-arm MajesTEC-1 study are available for the assessment of the additional benefit of teclistamab.
- The results of the submitted single-arm MajesTEC-1 trial 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 additional benefit from teclistamab as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulator, a proteasome inhibitor and an anti-CD38antibody, and who have shown disease progression during their most recent treatment, there is no proof.
Courtesy translation only, please refer to the German original.
Associated procedures
| Teclistamab (1) | Tecvayli® | Janssen-Cilag GmbH | Multiple myeloma, at least 3 prior therapies | 1,210–1,310 | 100% additional benefit not proven |
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