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PMID
Authors
Title Vitrakvi (larotrectinib) FDA Drug Label
Journal
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210861
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Larotrectinib Vitrakvi LOXO-101|ARRY-470 Trk Receptor Inhibitor (Pan) 29 Vitrakvi (larotrectinib) binds to and prevents activation of TRK receptors (NTRK1, -2, -3), resulting in decreased growth and increased apoptosis in Trk-expressing tumor cells (PMID: 29532798). Vitrakvi (larotrectinib) is FDA approved for use in adult and pediatric patients with solid tumors that have progressed, are metastatic, or are not surgically resectable and have an NTRK fusion without acquired resistance mutations (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
NTRK1 fusion NTRK1 G595R Advanced Solid Tumor resistant Larotrectinib FDA contraindicated Actionable Vitrakvi (larotrectinib) is contraindicated for solid tumors with an NTRK1 fusion harboring a known NTRK1 resistance mutation, including G595R (FDA.gov). detail...
NTRK1 fusion Advanced Solid Tumor sensitive Larotrectinib FDA approved Actionable In three trials that supported FDA approval, Vitrakvi (larotrectinib) treatment resulted in an overall response rate of 75% (41/55) in adult and pediatric patients with advanced solid tumors harboring either an NTRK1, NTRK2, or NTRK3 fusion, including 7 patients achieving a complete response and 34 patients achieving a partial response (PMID: 29466156; NCT02122913, NCT02637687, NCT02576431). detail... 29466156 detail...
NTRK2 fusion Advanced Solid Tumor sensitive Larotrectinib FDA approved Actionable In three trials that supported FDA approval, Vitrakvi (larotrectinib) treatment resulted in an overall response rate of 75% (41/55) in adult and pediatric patients with advanced solid tumors harboring either an NTRK1, NTRK2, or NTRK3 fusion, including 7 patients achieving a complete response and 34 patients achieving a partial response (PMID: 29466156; NCT02122913, NCT02637687, NCT02576431). detail... 29466156