NDAORALCAPSULEPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROZLYTREK (entrectinib) is an oral small-molecule tyrosine kinase inhibitor approved in August 2019 for patients with NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer. The drug works by inhibiting tropomyosin receptor kinase (TRK) and ROS1 signaling pathways, blocking tumor cell proliferation in patients with these rare genomic alterations.
Peak11.8 years to LOE
Product is in peak commercial phase with established market presence, likely supporting mid-to-large brand team and indication expansion efforts.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
Started May 2026
52 enrolled
High Grade GliomaCNS Tumor
DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.
Started Nov 2025
30 enrolled
Haematological MalignancyMalignancyMalignant Neoplasm+8 more
Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
Started Oct 2025
50 enrolled
Non-small Lung Cancer
Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
Started Oct 2022
13 enrolled
Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
Started Sep 2021
217 enrolled
Carcinoma, Non-Small-Cell Lung
Worked on ROZLYTREK at Roche? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.