ROZLYTREK
PeakNDAORALCAPSULEPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
ROZLYTREK by Roche is (trk) trka, trkb, and trkc (encoded by the neurotrophic tyrosine receptor kinase [ ntrk ] genes ntrk1, ntrk2, and ntrk3 , respectively), proto-oncogene tyrosine-protein kinase ros1 (ros1), and anaplastic lymphoma kinase (alk) with ic 50 values of 0. Approved for detected by an fda-approved test, detected by an fda-approved test without a known acquired resistance mutation, where surgical resection is likely to result in severe morbidity. First approved in 2019.
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 in August 2019 for treating tumors with NTRK, ROS1, or ALK fusion mutations. The drug works by potently inhibiting tropomyosin receptor kinase (TRK) proteins, ROS1, and anaplastic lymphoma kinase (ALK) at nanomolar concentrations, thereby blocking oncogenic signaling pathways driven by gene fusions. ROZLYTREK demonstrates strong central nervous system penetration with brain-to-plasma ratios of 0.4–2.2, enabling treatment of intracranial tumors. It represents a precision oncology approach targeting rare fusion-driven cancers across multiple tumor types, positioning it as a foundational therapy in the TRK/ROS1/ALK inhibitor class.
$0.0BPart D
Mechanism of Action
(TRK) TRKA, TRKB, and TRKC (encoded by the neurotrophic tyrosine receptor kinase [ NTRK ] genes NTRK1, NTRK2, and NTRK3 , respectively), proto-oncogene tyrosine-protein kinase ROS1 (ROS1), and anaplastic lymphoma kinase (ALK) with IC 50 values of 0.1 to 2 nM. Entrectinib also inhibits JAK2 and TNK2…
Indications (3)
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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.