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Larotrectinib

(Vitrakvi®)

Vitrakvi®

Drug updated on 9/4/2024

Dosage FormCapsule (oral; 25 mg, 100 mg); Oral Solution (oral; 20 mg/mL)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • 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.
  • Indicated for the treatment of adult and pediatric patients with solid tumors that are metastatic or where surgical resection is likely to result in severe morbidity.
  • Indicated for the treatment of adult and pediatric patients with solid tumors that have no satisfactory alternative treatments or that have progressed following treatment.

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Summary
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  • Vitrakvi (larotrectinib) 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, for the treatment of adult and pediatric patients with solid tumors that are metastatic or where surgical resection is likely to result in severe morbidity, and for the treatment of adult and pediatric patients with solid tumors that have no satisfactory alternative treatments or that have progressed following treatment.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • In a virtual cohort of 43 patients with NTRK gene fusion-positive tumors treated with TRK inhibitors, including those with central nervous system tumors, benefits of these agents were confirmed in this specific subgroup.
  • Larotrectinib demonstrated effectiveness across a range of tumor types, with a pooled objective response rate of 75% (95% CI: 61-85) compared to entrectinib's 57.4% (95% CI: 43.2-70.8), and showed particular efficacy in later lines of therapy for advanced or metastatic solid tumors with NTRK gene fusions in both adult and pediatric populations.
  • Historical comparisons suggest that larotrectinib is more efficacious than traditional treatments across seven reviewed tumor types, including non-small cell lung cancer, colorectal cancer, and gliomas, among others.
  • Preliminary data suggest that NTRK inhibitors, including larotrectinib, are well tolerated.
  • No specific safety concerns or adverse effects are detailed in the provided studies.
  • The evidence source primarily focuses on adult and pediatric patients with NTRK gene fusion-positive tumors, including specific subgroups such as those with central nervous system tumors and various advanced or metastatic solid tumors (non-small cell lung cancer, colorectal cancer, thyroid cancer, gliomas, soft tissue sarcoma, salivary gland cancer, and infantile fibrosarcoma). There is no additional population type or subgroup information beyond these considerations.