NDAORALSOLUTIONPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
4/8 — Partial
Priority Review
VITRAKVI (larotrectinib) by Bayer is tropomyosin receptor kinases inhibitors [moa]. First approved in 2018.
Drug data last refreshed 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VITRAKVI (larotrectinib) is an oral tropomyosin receptor kinases (TRK) inhibitor approved for TRK fusion-positive solid tumors across pediatric and adult populations. It works by selectively blocking TRK proteins that drive cancer cell growth in tumors with specific genetic fusions. This precision medicine approach targets a rare but actionable molecular driver across multiple cancer types.
Peak10.5 years to LOE
Product is at peak commercial maturity with a rare disease focus; smaller commercial infrastructure and highly specialized MSL/field roles focused on oncology centers and molecular testing partnerships.
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 (9)
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
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
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Started Apr 2020
54 enrolled
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
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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.