Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 25 mg, 100 mg),Oral Solution (oral; 20 mg/mL) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- For the treatment of adult and pediatric patients with solid tumors that have no satisfactory alternative treatments or that have progressed following treatment.
Summary
- Larotrectinib (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.
- Two systematic reviews/meta-analyses were reviewed which provided insights into the efficacy and safety of larotrectinib (Vitrakvi).
- The first review conducted a historical comparison between larotrectinib (Vitrakvi) and current histology-based standard care treatments used in various types of cancer including non-small cell lung cancer, colorectal cancer, thyroid cancer among others; it found that larotrectinib provides positive outcomes across these tumor types especially when compared to later lines of therapy.
- In both adult and pediatric patients with advanced or metastatic solid tumors known to harbor NTRK gene fusions, this drug was shown to be an efficacious treatment option according to the same study.
- The second review focused on assessing clinical data for seven interventions involving NTRK inhibitors; pooled analyses reported objective response rates of 75% for larotrectinib (Vitrakvi), indicating its impressive clinical benefit despite limited availability economic or quality-of-life evidence related to its use.
- This meta-analysis also highlighted how well-tolerated Vitrakvi (larotractenb) was by patients while emphasizing the need for further corroboration from existing studies as well as real-world data collection efforts regarding its effectiveness against NTRK gene fusion-positive tumors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vitrakvi (larotrectinib) Prescribing Information. | 2023 | Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Combined clinical and pharmacoeconomic report: larotrectinib (Vitrakvi). | 2021 | CADTH |
| Transforming approaches to treating TRK fusion cancer: historical comparison of larotrectinib and histology-specific therapies. | 2021 | Current medical research and opinion |
| Systematic review of neurotrophic tropomyosin-related kinase inhibition as a tumor-agnostic management strategy. | 2020 | Future Oncology |
| Assessment report: Vitrakvi. | 2019 | EMA |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Metastatic pancreatic cancer: ASCO guideline update. | 2020 | Journal of Clinical Oncology |