NDAORALPELLETSPriority Review
Approved
Oct 2023
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
14
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROZLYTREK (entrectinib) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA on October 20, 2023. It is indicated across a broad spectrum of malignancies including non-small cell lung cancer, breast cancer, pancreatic cancer, and hematologic malignancies, among others. The drug targets multiple kinase pathways implicated in oncogenic transformation. It represents Roche's expansion into precision oncology with oral bioavailability in pellet formulation.
$0.0BPart D
6mo to LOEMechanism 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
220 enrolled
Carcinoma, Non-Small-Cell Lung
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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.