DRUGDOCS | Retevmo®

Drug updated on 10/28/2024

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.

Summary
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This summary is based on the review of two randomized controlled trial(s). ^[1-2]
In patients with RET (rearranged during transfection) fusion-positive non-small-cell lung cancer (NSCLC), selpercatinib demonstrated a median progression-free survival (PFS) of 24.8 months (95% CI (confidence interval), 16.9 to not estimable), compared to 11.2 months (95% CI, 8.8 to 16.8) for the control, with a hazard ratio (HR) for progression or death of 0.46 (95% CI, 0.31 to 0.70), P<0.001.
In patients with RET-mutant medullary thyroid cancer (MTC), selpercatinib significantly improved PFS with a hazard ratio for disease progression or death of 0.28 (95% CI, 0.16 to 0.48), P<0.001, and a 12-month PFS rate of 86.8% (95% CI, 79.8 to 91.6) compared to 65.7% (95% CI, 51.9 to 76.4) for the control group.
Selpercatinib achieved higher overall response rates in both NSCLC (84%, 95% CI, 76 to 90) and MTC (69.4%, 95% CI, 62.4 to 75.8) compared to control treatments.
In medullary thyroid cancer (MTC) patients, 38.9% of those treated with selpercatinib required dose reductions compared to 77.3% in the control group. Treatment discontinuation due to adverse events was 4.7% for selpercatinib versus 26.8% for the control.
For non-small-cell lung cancer (NSCLC), adverse events with selpercatinib were consistent with previous reports, but no detailed breakdown was provided.
The studies focused on patients with advanced RET fusion-positive non-small-cell lung cancer (NSCLC) and RET-mutant medullary thyroid cancer (MTC). In both populations, selpercatinib demonstrated significant improvements in progression-free survival, overall response rates, and treatment failure-free survival compared to control treatments.

Product Monograph / Prescribing Information

Document Title	Year	Source
Retevmo (selpercatinib) Prescribing Information.	2024	Lilly USA, LLC., Indianapolis, IN

Randomized Controlled Trials

Document Title	Sex Distribution	Year	Source
First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC	261Subjects F: 55% M: 45%	2023	The New England Journal of Medicine
Phase 3 Trial of Selpercatinib in Advanced RET-Mutant Medullary Thyroid Cancer	291Subjects F: 37% M: 63%	2023	The New England Journal of Medicine

Document Title

First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC

Sex Distribution:

F:55%

M:45%

261Subjects

Year:

2023

Source:The New England Journal of Medicine

Document Title

Phase 3 Trial of Selpercatinib in Advanced RET-Mutant Medullary Thyroid Cancer

Sex Distribution:

F:37%

M:63%

291Subjects