NDAORALCAPSULEPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
6/8 — Strong
Priority Review
VITRAKVI (larotrectinib) by Bayer is tropomyosin receptor kinases inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2018.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VITRAKVI (larotrectinib) is an oral small-molecule tropomyosin receptor kinase (TRK) inhibitor approved by the FDA in November 2018 for TRK fusion-positive solid tumors and primary CNS lymphomas. It works by selectively inhibiting TRK kinase activity to block tumor cell proliferation driven by neurotrophic tyrosine kinase receptor (NTRK) gene fusions.
$30MPart D
Peak10.7 years to LOEVITRAKVI is in peak sales phase with modest Part D spending ($30M in 2023), indicating a mature specialty product with stable but limited market scope requiring focused medical affairs and targeted sales efforts.
Mechanism of Action
Tropomyosin Receptor Kinases Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer
Started Feb 2024
13 enrolled
Differentiated Thyroid CancerPediatric CancerCancer+1 more
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
Started Mar 2022
93 enrolled
Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene FusionInfantile Fibrosarcoma
A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice
Started Dec 2021
368 enrolled
Solid Tumors Harboring NTRK Fusion
NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
Started Nov 2021
100 enrolled
Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
A Retro-/Prospective, Non-interventional, Cohort Study in Adult Patients With Locally Advanced or Metastatic Tumors With a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion, Treated With Larotrectinib
Started Feb 2021
26 enrolled
Solid Tumor, AdultLocally Advanced Solid TumorMetastatic Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.