NDAORALCAPSULEPriority Review
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
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 32m 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 the treatment of RET-altered cancers. It selectively inhibits RearrangedDuringTransfection (RET) protein, a driver mutation in specific lung and thyroid malignancies. The drug represents a precision oncology approach targeting patients with RET fusion-positive or RET mutation-positive tumors.
Peak16.0 years to LOE
GAVRETO is in peak commercial lifecycle with established market presence; the commercial team likely remains at optimal size with focus on market penetration and indication expansion.
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 (5)
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
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
Non-Small Cell Lung CancerMedullary Thyroid Cancer
Worked on GAVRETO at Rigel Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.