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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: 10/30/2019
Orphan Designation: Treatment of RET-fusion-positive non-small cell lung cancer
Orphan Designation Status: Designated/Approved
Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company
701 Gateway Boulevard, Suite 420
South San Francisco, California 94080
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: 05/08/2020
Approved Labeled Indication: RETEVMO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
Exclusivity End Date: 05/08/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
2 Generic Name: selpercatinib
Trade Name: Retevmo
Marketing Approval Date: 09/21/2022
Approved Labeled Indication: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
Exclusivity End Date: 09/21/2029 
Exclusivity Protected Indication* :  treatment of adult patients with locally advanced non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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