Drug updated on 12/11/2024
| 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
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Objective Response Rate (ORR) and Disease Control Rate (DCR): The Objective Response Rate (ORR) for Rearranged during Transfection (RET)-specific drugs, including pralsetinib, ranged from 60–89%, with a combined ORR of 67% (95% confidence interval (CI): 0.64–0.70, P < 0.01). The Disease Control Rate (DCR) was reported as 92% (95% CI: 0.91–0.94, P < 0.01).
- Complete Response (CR), Partial Response (PR), and Progression-Free Survival (PFS): Complete Response (CR) ranged from 0–11%, and Partial Response (PR) ranged from 55–89%. Median Progression-Free Survival (mPFS) was 16.09 months (95% CI: 11.66–20.52, P < 0.01).
- Subgroup Effectiveness: Intracranial ORR for treated patients with RET mutation was 86% (95% CI: 0.74–0.96, P < 0.01). ORR was higher in untreated patients compared to treated ones (hazard ratio (HR) = 0.44; 95% CI: 0.35–0.56, P < 0.01).
- Grade 3 or Higher Adverse Events: Grade 3 or higher adverse events occurred in 28–53% of patients, with hypertension, changes in Alanine Aminotransferase (ALT), QT prolongation, neutropenia, and pneumonitis being commonly reported. Neutropenia and anemia were the most significant grade 3–4 adverse events, each observed in 13% of patients.
- Comparison to Other Drugs: Pralsetinib and selpercatinib demonstrated similar safety profiles, with comparable rates of grade 3 or higher adverse events.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gavreto (pralsetinib) Prescribing Information. | 2024 | 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 |
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 |