^
Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Multiple Myeloma |
| Drug: | Xpovio (selinexor) (XPO1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Antengene Announces XPOVIO® Regulatory Approval in Macau for the Treatment of Relapsed and/or Refractory Multiple Myeloma
Published date:
12/06/2023
Excerpt:
Antengene Corporation Limited...announced that the Pharmaceutical Administration Bureau of Macau has approved a New Drug Application (NDA) for XPOVIO® (selinexor), applicable in combination with dexamethasone (Xd), for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Source:
Title:
Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO® (selinexor) in Combination with Bortezomib and Dexamethasone for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy
Published date:
02/21/2023
Excerpt:
Karyopharm Therapeutics Inc...and the Menarini Group...announced that the United Kingdom's (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing Authorization for NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. With this approval extending NEXPOVIO's indication in Great Britain, the conditional marketing authorization is now converted to full approval.
Secondary therapy:
bortezomib
Source:
Title:
Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy
Published date:
07/21/2022
Excerpt:
Karyopharm Therapeutics Inc. and the Menarini Group...announced that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy. With this approval for the extension of NEXPOVIO's indication in the European Union (EU), the conditional marketing authorisation is now converted to a full approval.
Secondary therapy:
bortezomib
Source:
Title:
FORUS THERAPEUTICS INC (“FORUS”) ANNOUNCES XPOVIO® (SELINEXOR) IS AUTHORIZED FOR SALE BY HEALTH CANADA
Published date:
06/07/2022
Excerpt:
FORUS Therapeutics Inc...is pleased to announce...XPOVIO (selinexor) was authorized for sale by Health Canada in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy...Approval was based on the Phase 3 BOSTON trial of XPOVIO in combination with once-weekly bortezomib and low-dose dexamethasone compared to twice-weekly bortezomib and low-dose dexamethasone in patients with relapsed or refractory multiple myeloma.
Secondary therapy:
bortezomib
Source:
Title:
Karyopharm's Partner Antengene Receives Approval in China for XPOVIO® (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Published date:
12/17/2021
Excerpt:
Karyopharm Therapeutics Inc...has been granted conditional approval for marketing by the China National Medical Products Administration (NMPA) for XPOVIO® (selinexor), a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have received prior therapies and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Source:
Title:
Antengene Announces the Approval of First-in-Class Oral XPO1 Inhibitor Selinexor in South Korea for the Treatment of Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma
Published date:
08/02/2021
Excerpt:
Antengene Corporation Limited...today announced that through a priority review process, the South Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s New Drug Application (NDA) for the Orphan Drug-designated first-in-class oral inhibitor of XPO1, selinexor (XPOVIO®), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM)...
Source:
Title:
Karyopharm Receives Conditional Marketing Authorization in the United Kingdom (UK) for NEXPOVIO (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma
Published date:
06/02/2021
Excerpt:
Karyopharm Therapeutics Inc...today announced that on May 26, 2021 the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization for NEXPOVIO (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple myeloma...
Trial ID:
Source:
Title:
Karyopharm Receives Conditional Marketing Authorization from the European Commission for NEXPOVIO (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma
Published date:
03/29/2021
Excerpt:
Karyopharm Therapeutics...announced that the European Commission (EC) has granted conditional marketing authorization for NEXPOVIO (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple myeloma in adult patients...
Source:
Title:
Karyopharm Announces XPOVIO® (selinexor) Receives Regulatory Approval in Israel for the Treatment of Patients with Multiple Myeloma and Diffuse Large B-Cell Lymphoma
Published date:
02/04/2021
Excerpt:
Karyopharm Therapeutics Inc...has received a principal approval letter from the Israeli Ministry of Health, Israel's regulatory agency responsible for the approval of new medicines, granting the approval of XPOVIO® (selinexor) for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma (DLBCL). The approved indications for XPOVIO are a) in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma...
Source:
Excerpt:
XPOVIO is a nuclear export inhibitor indicated:… In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody
Source:
Published date:
04/12/2021
Excerpt:
Therapy for previously treated Multiple Myeloma…Other recommended regimens…selinexor/bortezomib/dexamethasone (once weekly)
Secondary therapy:
bortezomib
Source:
Title:
Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Published date:
02/03/2021
Excerpt:
Recommendations: Patients at third and subsequent lines of treatment: For triple-class refractory patients, Sd or belantamab mafodotin monotherapy is recommended [II, B], if available.
DOI:
10.1016/j.annonc.2020.11.014
Source:
Excerpt:
Multiple Myeloma: Therapy for previously treated multiple myeloma...Useful In Certain Circumstances…Selinexor/dexamethasone
Source:
Title:
Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma
Published date:
05/20/2022
Excerpt:
Karyopharm Therapeutics Inc...and the Menarini Group...announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received one to three prior lines of therapy...Karyopharm's application is supported by data from the Phase 3 BOSTON study, which evaluated the SVd triplet regimen in patients with relapsed or refractory multiple myeloma...
Secondary therapy:
bortezomib
Trial ID:
Source:
Title:
Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma
Published date:
04/10/2018
Excerpt:
Karyopharm Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.
