Selinexor (2) – Nexpovio®
Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone
Characteristics
| Start date | 01.10.2022 – Marketing authorisation: 26.03.2021 |
|---|---|
| Resolution | 16.03.2023 |
| INN | Selinexor |
| Brand name | Nexpovio® |
| Pharm. company |
Dossier: Stemline Therapeutics B.V.
New distributor: Menarini Stemline Deutschland GmbH |
| G-BA Procedure ID | D-864 |
| ATC code | L01XX66 Other antineoplastic agents (L01XX) |
| 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 |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
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Nexpovio, in combination with dexamethasone, is indicated for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory drugs and one anti-CD38 monoclonal antibody and who have experienced disease progression on their last therapy |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory drugs and one anti-CD38 monoclonal antibody and who have experienced disease progression on the last therapy | Atient-specific therapy with selection of: - Bortezomib monotherapy - Bortezomib + pegylated liposomal doxorubicin - Bortezomib + dexamethasone - Carfilzomib + lenalidomide and dexamethasone - Carfilzomib + dexamethasone - Daratumumab + lenalidomide + dexamethasone - Daratumumab + bortezomib + dexamethasone - Daratumumab + pomalidomide + dexamethasone - Daratumumab monotherapy - 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 - Doxorubicin - Carmustine (in combination with other cytostatic drugs and an adrenocortical hormone, especially prednisone) - vincristine - Dexamethasone - Prednisolone - prednisone - Best Supportive Care taking into account previous therapies and the degree and duration of response. |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (STORM, XPORT-MM-02) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + historical comparison) |
| ACT change | 29.03.2022 – Stellungnahme der Fachgesellschaften, Neuer G-BA Beschluss |
- Clinical trials
- The STORM trial is a completed, multicentre, single-arm trial in which the intervention consisted of selinexor plus dexamethasone.
- The XPORT-MM-028 trial is an ongoing, multicentre trial in which, amongst other things, different doses of selinexor and dexamethasone are being compared.
Adults with multiple myeloma who have previously received at least four lines of treatment and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory medicinal products and a monoclonal anti-CD38 antibody, and who have experienced disease progression during their most recent treatment
- The additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Selinexor (1) | Nexpovio® | Stemline Therapeutics B.V. | Multiple myeloma (MM) at least 1 prior therapy, combination with bortezomib and dexamethasone | 4,700–7,000 | 100% additional benefit not proven | |
| Selinexor (2) | Nexpovio® | Stemline Therapeutics B.V. | Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone | 570–1,130 | 100% additional benefit not proven |
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