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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: entrectinib
Trade Name: Rozlytrek
Date Designated: 07/05/2017
Orphan Designation: Treatment of NTRK fusion-positive solid tumors
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
MS#241A
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: entrectinib
Trade Name: Rozlytrek
Marketing Approval Date: 08/15/2019
Approved Labeled Indication: ROZLYTREK is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy
Exclusivity End Date: 08/15/2026 
Exclusivity Protected Indication* :  For the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy.
2 Generic Name: entrectinib
Trade Name: Rozlytrek
Marketing Approval Date: 10/20/2023
Approved Labeled Indication: treatment of adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy
Exclusivity End Date: 10/20/2030 
Exclusivity Protected Indication* :  treatment of pediatric patients older than 1 month up to 12 years of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy
*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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