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 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROZLYTREK (entrectinib) is an oral small-molecule tyrosine kinase inhibitor targeting TRK, ROS1, and ALK fusion proteins in patients with solid tumors. It is indicated for NTRK, ROS1, or ALK fusion-positive cancers where surgical resection would cause severe morbidity, with approval based on FDA-approved companion diagnostics. The drug crosses the blood-brain barrier effectively, enabling treatment of central nervous system metastases.
$0.016BPart D
PeakPeak lifecycle stage suggests mature commercial infrastructure with stable field operations; modest Part D spend of $16M indicates niche market with limited team expansion near-term.
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.