NDAORALCAPSULEPriority Review
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Mechanism of Action
Rearranged during Transfection (RET) Inhibitors
Pharmacologic Class:
Kinase Inhibitor
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
Loss of Exclusivity
LOE Date
Jul 7, 2042
199 months away
Patent Expiry
Jul 7, 2042
Exclusivity Expiry
Dec 1, 2027