NDAORALCAPSULEPriority Review
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
5/8 — Partial
Priority Review
GAVRETO (pralsetinib) by Rigel Pharmaceuticals is rearranged during transfection (ret) inhibitors [moa]. First approved in 2020.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GAVRETO (pralsetinib) is an oral RET kinase inhibitor approved by the FDA in September 2020 for patients with RET-altered cancers. It selectively targets the Rearranged during Transfection (RET) protein, a driver mutation in thyroid and lung cancers. The drug represents a precision medicine approach to treating genetically defined patient populations.
Peak15.8 years to LOE
Product is at peak commercial maturity with stable market penetration; commercial teams are focused on maximizing market share and indication expansion rather than growth-stage hiring.
Mechanism of Action
Rearranged during Transfection (RET) Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors
Started Mar 2026
12 enrolled
NSCLC (Non-small Cell Lung Cancer)Thyroid CancerSolid Tumor Malignancies+1 more
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).
Started Nov 2023
0Medullary Thyroid Cancer
External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
Started Dec 2020
279 enrolled
RET-fusion Non Small Cell Lung CancerLung NeoplasmCarcinoma, Non-Small-Cell Lung+14 more
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Started Jul 2020
223 enrolled
RET-fusion Non Small Cell Lung CancerLung NeoplasmCarcinoma, Non-Small-Cell Lung+14 more
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
Started Mar 2017
590 enrolled
RET-altered Non Small Cell Lung CancerMedullary Thyroid CancerRET-altered Papillary Thyroid Cancer+37 more
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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.