Drug updated on 3/28/2024
| Dosage Form | Capsule (oral: 100 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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).
- For treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
- 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).
Summary
- Pralsetinib (Gavreto) is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, as well as adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy.
- The drug is also used to treat adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory.
- Information about pralsetinib was derived from a systematic review/meta-analysis document. A total of one such document was reviewed in this process.
- According to a systematic review, objective-response, complete-response, and partial-response rates were found to be between 60%-89%, 0%-11%, and 55%-89% respectively when using RET-specific drugs like pralsetinib.
- Adverse events graded at level three or higher were observed in approximately 28% -53% of patients treated with these drugs. Common side effects included hypertension, changes in ALT levels, QT prolongation, neutropenia,and pneumonitis.
- Despite these adverse events,the study concluded that both selpercatinib another similar drug,and pralsetinib were effective treatments for most patients suffering from RET-altered tumors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gavreto (pralsetinib) Prescribing Information. | 2022 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Clinical, pharmacoeconomic, and stakeholder input combined report. | 2023 | CADTH |
| Efficacy and Safety of RET-Specific Kinase Inhibitors in RET-Altered Cancers: A Systematic Review. | 2023 | Cancer investigation |
| Pralsetinib for treating RET fusion-positive advanced non-small-cell lung cancer. | 2022 | NICE |
| Assessment report: Gavreto. | 2021 | EMA |
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 |