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Molecular Profile RET fusion
Therapy Pralsetinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RET fusion lung non-small cell carcinoma sensitive Pralsetinib FDA approved - Has Companion Diagnostic Actionable In a Phase I/II trial (ARROW) that supported FDA approval, Gavreto (pralsetinib) treatment was well-tolerated, resulting in an objective response rate of 61% (53/87) and 70% (19/27) in previously treated and treatment-naive patients with RET fusion-positive non-small cell lung cancer, respectively (PMID: 34118197; NCT03037385). detail... 34118197 detail...
RET fusion lung non-small cell carcinoma sensitive Pralsetinib Guideline Actionable Gavreto (pralsetinib) is included in guidelines as a first-line therapy for patients with metastatic non-small cell lung cancer harboring RET fusions (PMID: 36872130; ESMO.org). detail... 36872130
RET fusion lung non-small cell carcinoma sensitive Pralsetinib Clinical Study Actionable In a retrospective study, Gavreto (pralsetinib) treatment resulted in an overall response rate of 55.6%, a disease control rate of 72.2%, a median progression-free survival of 10.7 months, and overall survival of 21.2 months in patients with metastatic non-small cell lung cancer harboring a RET fusion (n=36) including KIF5B-RET (n=13) and CCDC6-RET (n=2) (PMID: 39241296). 39241296
RET fusion lung non-small cell carcinoma sensitive Pralsetinib Clinical Study Actionable In a retrospective study, Gavreto (pralsetinib) treatment resulted in an objective response rate (ORR) of 61% (39/59, 2 complete responses (CR), 37 partial responses (PR)) and a disease control rate (DCR) of 79.7% in non-small cell lung cancer patients harboring RET fusions, and an intracranial ORR of 66.7% (4/6, 3 CR and 1 PR), an intracranial DCR of 100% in patients with measurable brain metastases (PMID: 36379124). 36379124
RET fusion lung non-small cell carcinoma sensitive Pralsetinib Guideline Actionable Gavreto (pralsetinib) is included in guidelines as a preferred first-line therapy (category 1) for patients with advanced or metastatic non-small cell lung cancer harboring a RET fusion (NCCN.org). detail...
PubMed Id Reference Title Details
NCCN.org Full reference...
ESMO Clinical Practice Guidelines Full reference...
Full reference...
Gavreto (pralsetinib) FDA Drug Label Full reference...
(34118197) Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Full reference...
(36379124) Pralsetinib in RET fusion-positive non-small-cell lung cancer: A real-world data (RWD) analysis from the Italian expanded access program (EAP). Full reference...
(36872130) Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Full reference...
(39241296) Efficacy and safety of pralsetinib in patients with RET fusion positive non-small cell lung cancer: An observational real world study. Full reference...