ROZLYTREK
Post-LOENDAORALPELLETSPriority Review
Approved
Oct 2023
Lifecycle
Post-LOE
Competitive Pressure
35/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROZLYTREK (entrectinib) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA in October 2023. The drug targets NTRK gene fusions and ROS1 rearrangements in solid tumors. It represents a precision oncology approach for patients with specific genomic alterations.
$16MPart D
LOE ApproachingPost-LOEProduct is in early commercial phase with modest Part D adoption; teams should expect transition planning toward LOE in 2026.
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.
Why This Matters for Your Career
Patent cliff in less than a year — expect lifecycle management and generic defense hiring
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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.