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

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.

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

FDA Approved Products

XPOVIO
Manufacturer:Karyopharm Therapeutics Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2022/07/25
NDC:72237-101
XPOVIO
Manufacturer:Karyopharm Therapeutics Inc.
Route:ORAL
Strength:60 mg in 1 1
Approved: 2022/07/25
NDC:72237-104
XPOVIO
Manufacturer:Karyopharm Therapeutics Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2022/07/25
NDC:72237-103
XPOVIO
Manufacturer:Karyopharm Therapeutics Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2022/07/25
NDC:72237-102

Singapore Approved Products

XPOVIO FILM-COATED TABLETS 20MG
Manufacturer:Catalent CTS, LLC, Pharma Packaging Solutions, LLC (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:20.0mg
Online:Yes
Approved: 2022/03/01
Approval:SIN16434P

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