Larotrectinib
Other Protein Kinase Inhibitors
Sold as VITRAKVI
- Drug class
- Other Protein Kinase Inhibitors
- Availability
- Prescription only
- Routes
- Oral, Oropharyngeal
- Markets covered
- 4
- Products on record
- 7
- FDA reports (12 mo)
- 58
Overview
Plain-language summary, compiled from the cited regulatory records
Larotrectinib is a medication classified as an Other Protein Kinase Inhibitor [1]. It is approved for the treatment of adult and pediatric patients diagnosed with solid tumors that possess a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without any known acquired resistance mutation [1]. This treatment is intended for tumors that are metastatic, or where surgical removal is likely to cause severe morbidity, and for which no satisfactory alternative treatments exist or have progressed following prior therapy [1]. Patient selection for this therapy should be based on an approved diagnostic test [1].
Larotrectinib is available under the brand name VITRAKVI [1]. In the past 12 months, there have been 58 adverse event reports associated with this active ingredient [2]. Common reactions observed include disease progression, fatigue, nausea, and peripheral neuropathy [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 3 | March 22, 2025 |
| GB United Kingdom | MHRA | 2 | February 20, 2026 |
| US United States | FDA | 1 | May 22, 2026 |
| EU European Union | EMA | 1 | March 11, 2026 |
CACanada· Health Canada
3 products
Uses
VITRAKVI (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumours that: • have a Neurotrophic Tyrosine Receptor 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 treatment options.
This indication is approved based on overall response rate (ORR) and duration of response (DOR) in a pooled patient population in which most patients had rare tumours (see 14 CLINICAL TRIALS). 1 Mechanism of Action). VITRAKVI should only be administered under the supervision of a health professional experienced in the use of antineoplastic agents.
1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of VITRAKVI in pediatric patients 28 days and older were established based upon data from three multicenter, open-label, single-arm clinical studies. 3 Pediatrics).
GBUnited Kingdom· MHRA
2 products
Uses
1).
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE 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.
1) ]. VITRAKVI is a kinase inhibitor 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. 1 )
EUEuropean Union· EMA
1 product
Uses
1).
How to take
Drug interactions
Known interactions involving Larotrectinib. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 405. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02490315 · revised March 22, 2025
- [2]MHRA (UK) · PLGB000100741 · revised February 20, 2026
- [3]FDA DailyMed · 0c8ca614-58b2-4a… · revised May 22, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/004919 · revised March 11, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.