MedPath

Selinexor

Generic Name
Selinexor
Brand Names
Xpovio 100 Mg Once Weekly Carton, Nexpovio
Drug Type
Small Molecule
Chemical Formula
C17H11F6N7O
CAS Number
1393477-72-9
Unique Ingredient Identifier
31TZ62FO8F
Background

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

A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R/R NKTCL

Phase 1
Not yet recruiting
Conditions
Natural Killer/T-cell Lymphoma
Relapsed or Refractory Lymphoma Including ENKL
Interventions
First Posted Date
2025-05-11
Last Posted Date
2025-05-11
Lead Sponsor
Fudan University
Target Recruit Count
68
Registration Number
NCT06966154
Locations
🇨🇳

Dept of lymphoma and medical oncology, Shanghai Cancer Center, Shanghai, Shangai, China

Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients

Phase 2
Not yet recruiting
Conditions
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Interventions
First Posted Date
2025-03-28
Last Posted Date
2025-03-28
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
20
Registration Number
NCT06900088
Locations
🇨🇳

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China., Tianjin, China

Second-line Immunotherapy for ES-SCLC

Not Applicable
Recruiting
Conditions
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Interventions
First Posted Date
2025-03-03
Last Posted Date
2025-03-03
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
30
Registration Number
NCT06853678
Locations
🇨🇳

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China

HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM

Phase 2
Not yet recruiting
Conditions
Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
Interventions
First Posted Date
2025-02-12
Last Posted Date
2025-02-12
Lead Sponsor
Duke University
Target Recruit Count
27
Registration Number
NCT06822972

Using Tumor Models to Determine Treatments

Phase 2
Not yet recruiting
Conditions
Pancreatic Ductal Carcinoma
Advanced Cancer
Epithelial Tumor
Interventions
First Posted Date
2025-02-06
Last Posted Date
2025-02-18
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
25
Registration Number
NCT06813079
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

SIL as Maintenance Therapy in Multiple Myeloma

Phase 2
Not yet recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2024-12-20
Last Posted Date
2024-12-20
Lead Sponsor
Navy General Hospital, Beijing
Target Recruit Count
50
Registration Number
NCT06744894

Selinexor Combined With BEAM for ASCT in R/R DLBCL With MYC Positive

Phase 2
Not yet recruiting
Conditions
Diffuse Large B Cell Lymphoma
Interventions
First Posted Date
2024-10-22
Last Posted Date
2024-10-22
Lead Sponsor
Ruijin Hospital
Target Recruit Count
82
Registration Number
NCT06652139

Twice-per-weekSelinexor, 2 Days Melphalan

Phase 3
Not yet recruiting
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2024-09-25
Last Posted Date
2024-09-25
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
126
Registration Number
NCT06613035
Locations
🇨🇳

Zhengzhou University First Affiliated Hospital, Zhengzhou, Henan, China

🇨🇳

Hebei Medical University Second Hospital, Shijiazhuang, hebeisheng, China

🇨🇳

The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army, Jinan, Shandong, China

and more 1 locations

A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

Phase 1
Recruiting
Conditions
Relapsed/Refractory Primary Central Nervous System Lymphoma
Interventions
Drug: Anti-PD-1 monoclonal antibody
First Posted Date
2024-08-15
Last Posted Date
2024-08-15
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
38
Registration Number
NCT06556199
Locations
🇨🇳

2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hanzhou, Zhejiang, China

Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma

Phase 1
Recruiting
Conditions
B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory
CNS Metastases
Interventions
First Posted Date
2024-08-14
Last Posted Date
2024-08-14
Lead Sponsor
Samsung Medical Center
Target Recruit Count
37
Registration Number
NCT06552559
Locations
🇰🇷

Samsung Cancer Research Institute, Seoul, Korea, Republic of

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath