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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: 11/21/2019
Orphan Designation: Treatment of RET fusion-positive or RET mutant thyroid cancers including poorly differentiated thyroid cancer, undifferentiated or anaplastic thyroid cancer, medullary thyroid cancer, and locally advanced or metastatic follicular or papillary thyroid 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 and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; ¿ Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
Exclusivity End Date: 05/08/2027 
Exclusivity Protected Indication* :  For the treatment of: adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; and, adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
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 advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy; and treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
Exclusivity End Date: 05/29/2031 
Exclusivity Protected Indication* :  treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy; and treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
*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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