ROZLYTREK
Rozlytrek (entrectinib) is a kinase inhibitor indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer. It is also approved for adult and pediatric patients older than one month with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known resistance mutation. This therapy is reserved for patients with metastatic disease or those for whom surgical resection would cause severe morbidity, specifically when the cancer has progressed following treatment or no satisfactory alternative therapies exist.
How ROZLYTREK Works
Entrectinib and its major active metabolite, M5, inhibit the tropomyosin receptor tyrosine kinases TRKA, TRKB, and TRKC, as well as ROS1 and ALK. In certain cancers, these kinases form fusion proteins that hyperactivate downstream signaling pathways, resulting in unconstrained cell proliferation. By blocking these specific kinase domains, the drug inhibits the growth of tumor cells harboring NTRK, ROS1, or ALK gene fusions. Furthermore, the drug demonstrates the ability to cross the blood-brain barrier, showing anti-tumor activity in the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2019-08-15
- Routes
- ORAL
- Dosage Forms
- CAPSULE, PELLETS
ROZLYTREK Approval History
What ROZLYTREK Treats
2 indicationsROZLYTREK is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- ROS1-positive metastatic non-small cell lung cancer (NSCLC) in adults
- NTRK gene fusion-positive solid tumors in adult and pediatric patients older than 1 month
ROZLYTREK Target & Pathway
ProTarget
A JAK family member critical for blood cell production and involved in myeloproliferative disorders. JAK2 mutations drive polycythemia vera and myelofibrosis. Inhibiting JAK2 reduces abnormal blood cell production and spleen enlargement.
ROZLYTREK Competitors
Pro10 other drugs also target JAK2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (JAK2). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ROZLYTREK FDA Label Details
ProIndications & Usage
FDA Label (PDF)ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 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, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is app...
ROZLYTREK Patents & Exclusivity
Patents (76 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.