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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: pralsetinib
Trade Name: Gavreto
Date Designated: 05/26/2020
Orphan Designation: Treatment of RET-fusion, RET-mutation, and TRKC-positive 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
Blueprint Medicines Corporation
45 Sidney Street
Cambridge, Massachusetts 02139
United States

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

Marketing approved:

1 Generic Name: pralsetinib
Trade Name: Gavreto
Marketing Approval Date: 12/01/2020
Approved Labeled Indication: Treatment of (1) 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; (2) 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: 12/01/2027 
Exclusivity Protected Indication* :  Treatment of (1) 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; (2) 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 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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