What Is Larotrectinib (Vitrakvi)? FDA Approval, Licensing in Turkey, and Reimbursement
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What Is Vitrakvi (Larotrectinib)?
Vitrakvi (active ingredient: larotrectinib) is one of the first "tumor-agnostic" cancer drugs, focusing solely on a particular genetic alteration (an NTRK gene fusion) regardless of where the cancer began in the body. Bayer developed this targeted molecule, a tropomyosin receptor kinase (TRK) inhibitor with high efficacy in both adult and pediatric patients positive for an NTRK gene fusion.
Vitrakvi Pricing
Vitrakvi is supplied as 56 capsules of 100 mg. The usual adult dosage is 100 mg twice daily.
As of June 2026 , current pharmacy retail prices are:
- Vitrakvi 100 mg 56 Hard Capsules: a retail price of approximately 331,438.02 TL.
- Vitrakvi 25 mg 56 Hard Capsules: a retail price of approximately 82,970.39 TL.
- Vitrakvi 20 mg oral solution: a retail price of approximately 118,465.90 TL.
*Prices may vary according to TİTCK pricing scales and current drug exchange-rate regulations.
Drug Profile and Basic Information
- FDA Approval: Yes (November 2018 - Accelerated Approval)
- Active Ingredient: Larotrectinib
- Class: TRK (Tropomyosin Receptor Kinase) Inhibitor
- Route of Administration: Oral (Capsule or Oral Solution)
- Criterion: Only for patients with NTRK gene fusion -positive disease that is metastatic or not suitable for surgery.
How Does It Work?
Larotrectinib targets the overactive signaling pathways produced by fusions of the NTRK1, NTRK2, and NTRK3 genes, which encode the TRKA, TRKB, and TRKC proteins. These gene fusions produce hybrid proteins that cause cells to grow and proliferate continuously.
How does Vitrakvi work?
- It binds to the kinase domain of TRK proteins within the cell.
- It blocks the signaling that triggers cancer growth.
- It is an example of "precision medicine" because it acts only on cells with the fusion.
FDA Approval History
- 26 November 2018: The FDA granted accelerated approval for NTRK fusion-positive solid tumors.
- September 2019: European Medicines Agency (EMA) approval.
- 2021: Long-term clinical data demonstrated durable responses in children and adults.
- 2023: New data on its efficacy in patients with brain metastases were shared.
Resistance Mechanisms
- Kinase Domain Mutations: "Solvent front" mutations that prevent drug binding (e.g., TRKA G595R).
- Alternative Pathway Activation: MAPK or MET pathways become active as bypass routes.
- Point Mutations: Gatekeeper mutations restrict the drug's access to the TRK protein.
Pharmacokinetics (Absorption, Distribution, Metabolism, Excretion)
Absorption: It reaches peak levels approximately 1 hour after oral administration. Mean bioavailability is 34%.
Distribution: It is 70% bound to plasma proteins. It crosses the blood-brain barrier (effective in brain metastases).
Metabolism: It is metabolized in the liver primarily by the CYP3A4 enzyme.
Excretion: Its half-life is approximately 3 hours. It is largely excreted through feces (64%) and urine (20%).
Dosing and Administration
- Adult Dose: 100 mg twice daily (morning/evening).
- Pediatric Dose: 100 mg/m² based on body surface area (BSA), without exceeding a maximum dose of 100 mg.
- Capsules should be swallowed whole with water, without opening them.
Drug Interactions and Warnings
- CYP3A4 Inhibitors: Grapefruit juice or certain antifungal drugs may increase Vitrakvi levels and should be avoided.
- CYP3A4 Inducers: Herbal products such as St. John's Wort may reduce the drug's effect.
- Liver Monitoring: Liver enzymes should be monitored every 2 weeks during the first month of treatment.
Most Common Adverse Effects
- Fatigue (37%)
- Nausea (29%)
- Dizziness (28%)
- Vomiting (26%)
- Anemia (24%)
- Increased AST/ALT (22%)
- Constipation (21%)
- Diarrhea (20%)
Patient Education: Tell your physician if neurological symptoms (loss of balance, tingling) or severe fatigue develop during treatment.
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