Drug updated on 9/4/2024
| 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.
Latest News
Summary
- Rozlytrek (entrectinib) is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test; 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; 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; and 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.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- The pooled analysis of four trials reported an objective response rate (ORR) of 57.4% (95% CI: 43.2-70.8) for entrectinib.
- In comparison, the pooled analysis from four trials for larotrectinib showed an objective response rate (ORR) of 75% (95% CI: 61-85).
- The study does not provide specific details regarding the effectiveness outcomes for different population types or subgroups.
- There is no safety information available in the reviewed studies.
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 |