Selinexor
Selinexor (Nexpovio, Stemline Therapeutics B.V.) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma2 | |||
None | + bortezomib and dexamethasone | 2L | After at least one prior therapy |
None | + dexamethasone | 3L+ | After at least four prior therapies; refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, with disease progression on the last therapy |
Full text of section 4.1 (therapeutic indications)
NEXPOVIO is indicated: • in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. • in combination with dexamethasone 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 agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Label history
9 changes to the Nexpovio label since 2022, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes