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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: selpercatinib
Trade Name: Retevmo
Date Designated: 05/19/2022
Orphan Designation: Treatment of tissue-agnostic RET fusion-positive solid tumors
Orphan Designation Status: Designated/Approved
Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
United States

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

Marketing approved:

1 Generic Name: selpercatinib
Trade Name: Retevmo
Marketing Approval Date: 09/21/2022
Approved Labeled Indication: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Exclusivity End Date: 09/21/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
2 Generic Name: selpercatinib
Trade Name: Retevmo
Marketing Approval Date: 05/29/2024
Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Exclusivity End Date: 05/29/2031 
Exclusivity Protected Indication* :  treatment of pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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