Overview
Selinexor is a first-in-class selective inhibitor of nuclear transport (SINE) compound. Selinexor, in combination with bortezomib and dexamethasone, is currently approved for the treatment of multiple myeloma, a type of cancer formed from antibody-producing plasma cells. This condition is typically treated with high dose bortezomib and dexamethasone chemotherapy followed by an autologous stem-cell transplant. Other chemotherapies for multiple myeloma include lenalidomide and dexamethasone, thalidomide, and may include melphalan if the patient is not eligible for transplant. Selinexor was also granted accelerated approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have gone through at least 2 lines of systemic therapy. The FDA approved Selinexor in June 2019. The use of selinexor in combination with bortezomib and dexamethasone was approved by Health Canada in June 2022 for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Indication
Selinexor is indicated in combination with bortezomib and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Selinexor is also indicated in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least four prior therapies and who are refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Selinexor is also indicated under an accelerated approval scheme for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including that arising from follicular lymphoma, in adult patients who have received at least two prior lines of systemic therapy. Continued approval for this indication may be contingent on verification in confirmatory clinical trials.
Associated Conditions
- Multiple Myeloma (MM)
- Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
- Relapsed Diffuse large B-cell lymphoma NOS
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/15 | Not Applicable | Not yet recruiting | |||
2025/08/22 | Not Applicable | Not yet recruiting | |||
2025/05/11 | Phase 1 | Recruiting | |||
2025/03/28 | Phase 2 | Not yet recruiting | |||
2025/03/03 | Not Applicable | Recruiting | |||
2025/02/12 | Phase 2 | Recruiting | |||
2025/02/06 | Phase 2 | Not yet recruiting | |||
2024/12/20 | Phase 2 | Not yet recruiting | Navy General Hospital, Beijing | ||
2024/10/22 | Phase 2 | Not yet recruiting | |||
2024/09/25 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Karyopharm Therapeutics Inc. | 72237-101 | ORAL | 20 mg in 1 1 | 7/25/2022 | |
| Karyopharm Therapeutics Inc. | 72237-102 | ORAL | 40 mg in 1 1 | 7/25/2022 | |
| Karyopharm Therapeutics Inc. | 72237-103 | ORAL | 50 mg in 1 1 | 7/25/2022 | |
| Karyopharm Therapeutics Inc. | 72237-104 | ORAL | 60 mg in 1 1 | 7/25/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| XPOVIO FILM-COATED TABLETS 20MG | SIN16434P | TABLET, FILM COATED | 20.0mg | 3/1/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XPOVIO selinexor 20 mg tablet blister pack | 346589 | Medicine | A | 3/8/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| XPOVIO | forus therapeutics inc. | 02527677 | Tablet - Oral | 20 MG | 7/7/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| NEXPOVIO 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1211537001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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