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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: 04/11/2018
Orphan Designation: Treatment of rearranged during transfection (RET)-rearranged non-small cell lung cancer (NSCLC), JAK1/2-positive NSCLC, or TRKC-positive NSCLC.
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080-4990
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: 09/04/2020
Approved Labeled Indication: treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
Exclusivity End Date: 09/04/2027 
Exclusivity Protected Indication* :  treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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