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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: 05/14/2014
Orphan Designation: Treatment of diffuse large B-cell lymphoma
Orphan Designation Status: Designated/Approved
Karyopharm Therapeutics, Inc.
2 Mercer Road
Natick, Massachusetts 01760
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: 06/22/2020
Approved Labeled Indication: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
Exclusivity End Date: 06/22/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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