VITRAKVI
Vitrakvi is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that harbor a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. It is used for patients whose tumors are metastatic or where surgical resection is likely to result in severe morbidity. This therapy is reserved for cases where no satisfactory alternative treatments exist or the disease has progressed following prior treatment. Patients are selected for therapy based on an FDA-approved test to confirm the presence of the gene fusion without a known acquired resistance mutation.
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.
Details
- Status
- Prescription
- First Approved
- 2018-11-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SOLUTION
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
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
ProIndications & Usage
FDA Label (PDF)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. Select patients for therapy based on an FDA-approved test [see Dosage and Administration ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a n...
VITRAKVI Patents & Exclusivity
Patents (78 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.