Vitrakvi FDA Approval History
Last updated by Judith Stewart, BPharm on April 14, 2025.
FDA Approved: Yes (First approved November 26, 2018)
Brand name: Vitrakvi
Generic name: larotrectinib
Dosage form: Capsules and Oral Solution
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Solid Tumors
Vitrakvi (larotrectinib) is a tropomyosin receptor kinase inhibitor used for the treatment of solid tumors.
- 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. - Tropomyosin receptor kinase (TRK) fusion cancer is diagnosed through the identification of NTRK gene fusions using specific tests.
- TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein (TRK fusion protein) which acts as an oncogenic driver for the spread and growth of tumors. TRK fusion proteins can be present in a wide range of solid tumors.
- Vitrakvi was first granted accelerated approval by the U.S. Food and Drug Administration (FDA) in November 2018. Full approval was granted in April 2025 based on the pooled analysis of data from three multicenter, open-label, single-arm clinical trials (LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687) and NAVIGATE (NCT02576431) of pediatric and adult patients with unresectable or metastatic solid tumors with an NTRK gene fusion (n=339). Results showed an overall response rate (ORR) of 60% (95% CI: 55%-65%) with a complete response (CR) rate of 24% and a partial response (PR) rate of 36%. Five percent of patients with complete response were pathological complete response. The median duration of response (DOR) was 43.3 months (95% CI: 32.5-NE (not evaluable)).
- Vitrakvi works by inhibiting the TRK family of proteins (TRKA, TRKB, and TRKC) to stop the growth of cancer cells.
- Vitrakvi is administered orally twice daily.
- Warnings and precautions associated with Vitrakvi include central nervous system (CNS) effects, skeletal fractures, hepatotoxicity, and embryo-fetal toxicity.
- Common (> 20%) adverse reactions include musculoskeletal pain, fatigue, vomiting, cough, constipation, pyrexia, diarrhea, nausea, abdominal pain, dizziness, and rash.
Common laboratory abnormalities include increased AST, increased ALT, anemia, hypoalbuminemia, increased alkaline phosphatase, leukopenia, lymphopenia, neutropenia, and hypocalcemia.
Development timeline for Vitrakvi
Further information
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