Summary

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• Gavreto (pralsetinib) is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, and for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• Objective-Response Rates (ORR) in RET-altered Tumors: Pralsetinib and selpercatinib showed ORRs ranging from 60% to 89%, with complete-response rates between 0% and 11%, and partial-response rates from 55% to 89% in patients with RET-altered tumors.
• RET Fusion-Positive NSCLC: Selective RET inhibitors, including pralsetinib, demonstrated an ORR of 67%, a disease control rate (DCR) of 92%, a median progression-free survival (mPFS) of 16.09 months, and an intracranial ORR of 86% in RET fusion-positive NSCLC patients.
• Subgroup Analysis: Untreated RET fusion-positive NSCLC patients exhibited a higher ORR compared to treated patients (HR = 0.44). Intracranial ORR in treated patients was 86%.
• Pralsetinib and selpercatinib were associated with Grade 3 or higher adverse events in 28-53% of patients, with common adverse events including hypertension, changes in ALT, QT prolongation, neutropenia, and pneumonitis.
• Major adverse events specifically reported include neutropenia (13%) and anemia (13%). However, detailed safety outcomes in specific population types or subgroups were not provided, and there is a noted lack of comparative safety evidence with other drugs.