VITRAKVI (larotrectinib sulfate)
VITRAKVI is indicated for the treatment of Solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; Metastatic solid tumors with NTRK gene fusion; Solid tumors with NTRK gene fusion where surgical resection is likely to result in severe morbidity; Solid tumors with NTRK gene fusion that have progressed following treatment or have no satisfactory alternative treatments.
How VITRAKVI Works
Larotrectinib is an inhibitor of the tropomyosin receptor kinases TRKA, TRKB, and TRKC, which are encoded by the NTRK1, NTRK2, and NTRK3 genes. In certain cancers, chromosomal rearrangements result in in-frame fusions of these genes, creating chimeric TRK fusion proteins that are constitutively activated. These proteins act as oncogenic drivers that promote the proliferation and survival of tumor cells. By inhibiting these specific kinases, larotrectinib provides anti-tumor activity in cells with constitutive TRK protein activation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-26
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- SOLUTION, CAPSULE
VITRAKVI Approval History
What VITRAKVI Treats
4 indicationsVITRAKVI is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation
- Metastatic solid tumors with NTRK gene fusion
- Solid tumors with NTRK gene fusion where surgical resection is likely to result in severe morbidity
- Solid tumors with NTRK gene fusion that have progressed following treatment or have no satisfactory alternative treatments
VITRAKVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT03155620 results posted | NCI-2017-01251 NCI-2017-01251, APEC1621SC | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) |
| NCT03213704 results posted | NCI-2017-01264 NCI-2017-01264, APEC1621A | Ph 2 | active not recruiting | Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial) |
| NCT04879121 | 2020-0564 NCI-2021-00338, 2020-0564 | Ph 2 | recruiting | Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors |
| NCT03834961 results posted | ADVL1823 NCI-2019-00015, ADVL1823 | Ph 2 | active not recruiting | Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VITRAKVI FDA Label Details
Indications & Usage
FDA Label (PDF)VITRAKVI is indicated for the treatment of Solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; Metastatic solid tumors with NTRK gene fusion; Solid tumors with NTRK gene fusion where surgical resection is likely to result in severe morbidity; Solid tumors with NTRK gene fusion that have progressed following treatment or have no satisfactory alternative treatments.
VITRAKVI Patents & Exclusivity
Patents (20 active)
Pro Intelligence Preview
Deep insights for VITRAKVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 78 active patents
Trial Analysis
- • 5 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment