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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: selinexor
Trade Name: XPOVIO
Date Designated: 01/05/2015
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
Karyopharm Therapeutics, Inc.
85 Wells Avenue, Suite 210
Newton, Massachusetts 02459
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: selinexor
Trade Name: XPOVIO
Marketing Approval Date: 07/03/2019
Approved Labeled Indication: XPOVIO is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) 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.
Exclusivity End Date: 07/03/2026 
Exclusivity Protected Indication* :  Indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) 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.
2 Generic Name: selinexor
Trade Name: Xpovio
Marketing Approval Date: 12/18/2020
Approved Labeled Indication: in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
Exclusivity End Date: 12/18/2027 
Exclusivity Protected Indication* :  for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, excluding adult patients covered by Xpovio's previous indication for multiple myeloma approved on July 3, 2019
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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