Drug updated on 5/17/2024
Dosage Form | Capsule (oral; 100 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
- Indicated for 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).
Latest News
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Summary
- Pralsetinib (Gavreto) is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer and advanced or metastatic RET fusion-positive thyroid cancer in adults and pediatric patients 12 years of age and older who require systemic therapy.
- Three studies were reviewed to gather information about pralsetinib's safety, effectiveness, and comparison with other drugs like selpercatinib, including considerations for different populations and subgroups.
- The studies reveal pralsetinib shows high efficacy in treating RET-altered tumors. Objective responses ranged from 60% to 89%, including complete and partial responses, and it was particularly effective among intracranial response subgroups, highlighting its potential advantages for specific populations.
- Safety profiles indicate grade ≥3 adverse events reported in up to half of the patients treated with pralsetinib. Common side effects included hypertension, changes in ALT levels, QT prolongation, neutropenia, pneumonitis, and significant occurrences of anemia, but these must be considered against its demonstrated effectiveness.
- Compared to selpercatinib, another drug used for similar conditions, both drugs are deemed effective while being generally well-tolerated by patients with RET-altered tumors according to one study review. However, direct comparisons between them remain controversial due to a lack of robust clinical evidence, according to some sources.
- Despite promising results shown by pralsetinib, there remains a level of uncertainty around cost-effectiveness estimates leading to it not being recommended routinely within national health settings based on the current data available.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Gavreto (pralsetinib) Prescribing Information. | 2023 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of RET-specific kinase inhibitors in RET-altered cancers: a systematic review. | 2023 | Cancer Investigation |
The efficacy and safety of selective RET inhibitors in RET fusion-positive non-small cell lung cancer: a meta-analysis. | 2023 | Investigational New Drugs |
Pralsetinib for RET fusion-positive advanced non-small-cell lung cancer: an evidence review group perspective of a nice single technology appraisal. | 2023 | Pharmacoeconomics |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Therapy for stage IV non–small-cell lung cancer with driver alterations: ASCO living guideline. | 2022 | Journal of Clinical Oncology |
2021 American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. | 2021 | Thyroid |
NCCN guidelines insights: non–small cell lung cancer, version 2.2021. | 2021 | Journal of the National Comprehensive Cancer Network |
Treating non-small cell lung cancer. | 2020 | American Cancer Society |