Drug updated on 4/18/2024
| Dosage Form | Capsule (oral; 100 mg, 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with ROSI-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDI-approved test.
- Indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation.
- Indicated for the treatment of adult and pediatric patients older than 1 month of age 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 older than 1 month of age with solid tumors that have progressed following treatment or have no satisfactory alternative therapy.
Summary
- Entrectinib (Rozlytrek) is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as well as for both adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, among other specific conditions.
- The information about Rozlytrek was obtained from a systematic review/meta-analysis that encompassed 27 published reports. This study focused on clinical outcomes pertaining to NTRK inhibitors, specifically comparing Rozlytrek and larotrectinib in terms of efficacy and safety profiles.
- According to the reviewed study, entrectinib has an objective response rate (ORR) of 57.4%, indicating that a significant percentage of patients experienced a reduction in tumor size or complete disappearance following treatment. However, larotrectinib had a higher ORR at 75%.
- Both drugs are mentioned as being well-tolerated, but detailed safety outcome comparisons were not provided, making a direct comparison difficult between Rozlytrek's and larotrectinib’s safety profiles.
- The indication for entrectinib spans across both the adult and pediatric populations over one month old, highlighting its wide applicability across different age groups; however, more comprehensive research is needed concerning long-term outcomes for subgroups, including durability of response, progression-free survival, overall survival, and quality of life assessments, beyond just ORR data points alone.
- Despite the promising efficacy profile shown by Rozlytrek, especially within a very specific patient population, there remains an absence of economic and quality of life evidence. This suggests future research areas to better understand these treatments’ impacts beyond just clinical efficacy, thus underscoring the importance of continued accumulation and analysis of both clinical and real-world data, especially considering the limited treatment options available for certain patient demographics like pediatrics and adults alike.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rozlytrek (entrectinib) Prescribing Information. | 2024 | Genentech., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Systematic review of neurotrophic tropomyosin-related kinase inhibition as a tumor-agnostic management strategy. | 2020 | Future Oncology |