Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 25 mg, 100 mg); Solution (oral; 20 mg/mL) |
| Drug Class | Kinase 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.
Latest News
Summary
- This summary is based on the review of three systematic reviews/meta-analyses. [1-3]
- Larotrectinib has demonstrated an Objective Response Rate (ORR) of 75% (95% Confidence Interval [CI]: 61–85) in patients with advanced or metastatic solid tumors harboring Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions, indicating significant clinical benefit as an NTRK inhibitor.
- The systematic review included both adult and pediatric patients across various tumor types, including non-small cell lung cancer, colorectal cancer, thyroid cancer, gliomas, soft tissue sarcoma, salivary gland cancer, and infantile fibrosarcoma, highlighting larotrectinib's superior efficacy compared to standard histology-based treatments in these populations.
- Specific subgroup analyses indicate that larotrectinib is particularly beneficial for patients with central nervous system tumors, further supporting its use in this cohort.
- Preliminary data indicate that NTRK inhibitors, including larotrectinib, are well tolerated among patients, with no specific significant safety concerns or adverse effects mentioned.
- Safety data for larotrectinib and entrectinib suggest both drugs are well tolerated, but detailed comparative safety outcomes were not provided.
- There is no population type or subgroup information available in the reviewed studies.
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 |
|---|---|---|
| NTRK Gene Fusions in Solid Tumors and TRK Inhibitors: A Systematic Review of Case Reports and Case Series | 2022 | Journal of Personalized Medicine |
| 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 |