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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  larotrectinib
Trade Name:  VITRAKVI
Date Designated:  05/09/2017
Orphan Designation:  Treatment of solid tumors with NTRK-fusion proteins
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/26/2018 
Approved Labeled Indication:  VITRAKVI® is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine 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 no satisfactory alternative treatments or that have progressed following treatment.
Exclusivity End Date:    11/26/2025 
Exclusivity Protected Indication* :  VITRAKVI® is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine 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 no satisfactory alternative treatments or that have progressed following treatment.
Bayer HealthCare Pharmaceuticals Inc.
100 Bayer Boulevard
Whippany, New Jersey 07981
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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