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Title | Vitrakvi (larotrectinib) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210861 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Larotrectinib | Larotrectinib | 119 | 10 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Larotrectinib | Vitrakvi | LOXO-101|ARRY-470|BAY2757556 | Trk Receptor Inhibitor (Pan) 31 | 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 |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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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... |
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 |
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... |