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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
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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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