Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 40 mg, 80 mg); Tablets (oral; 40 mg, 80 mg, 120 mg, 160 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.
- Indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
- Indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
- Indicated for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
Latest News
Summary
- Retevmo (selpercatinib) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test; for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy; for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate); and for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Selpercatinib (retevmo) shows an objective-response rate (ORR) ranging from 60% to 89%, a complete-response rate (CRR) between 0% and 11%, and a partial-response rate (PRR) ranging from 55% to 89%.
- Effectiveness outcomes for selpercatinib are comparable to those of pralsetinib, another RET-specific tyrosine kinase inhibitor, with no differentiation regarding their ORR, CRR, or PRR. 5. ≥Grade 3 Adverse Events: Reported in 28% to 53% of patients.
- Common Adverse Effects: Include hypertension, changes in ALT levels, QT prolongation, neutropenia, and pneumonitis.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Retevmo (selpercatinib) Prescribing Information. | 2024 | Lilly USA, LLC., Indianapolis, IN |
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 |
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 |
NCCN guidelines insights: non–small cell lung cancer, version 2.2021. | 2021 | Journal of the National Comprehensive Cancer Network |
Current guidelines for management of medullary thyroid carcinoma. | 2021 | Endocrinology and Metabolism |