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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
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.

Marketing approved:

1 Generic Name: larotrectinib
Trade Name: VITRAKVI
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.

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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