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Retevmo ® (selpercatinib) tablets
40 mg, 80 mg, 120 mg, 160 mg
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What was the incidence of slipped capital femoral epiphysis in pediatric patients taking Retevmo® (selpercatinib)?
One adolescent (3.4%) in LIBRETTO-121 and 1 adolescent (3.7%) in LIBRETTO-531 experienced slipped capital femoral epiphysis.
Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis (SCFE/SUFE) in Pediatric Patients Taking Selpercatinib
Slipped capital femoral epiphysis/slipped upper femoral epiphysis (SCFE/SUFE) occurred in 1 adolescent (3.7% of 27 patients) receiving selpercatinib in LIBRETTO-121 and 1 adolescent (0.5% of 193 patients) receiving selpercatinib in LIBRETTO-531.1
Patient Monitoring for Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis
Monitor growth plates in pediatric patients with open growth plates. Consider interrupting or discontinuing therapy based on the severity of any growth plate abnormalities and based on an individual risk-benefit assessment.1
Monitor patients for symptoms indicative of SCFE/SUFE and treat as medically and surgically appropriate.1
Pediatric patients and caregivers should be advised to contact their healthcare provider promptly to report any signs and symptoms indicative of SCFE/SUFE.1
Symptoms of Slipped Capital Femoral Epiphysis/Slipped Upper Femoral Epiphysis
Slipped capital femoral epiphysis is characterized by backward and downward movement of the upper part of the femur bone (proximal femoral epiphysis) on the femoral neck (metaphysis) through the growth plate (epiphyseal plate).2
Slipped capital femoral epiphysis/slipped upper femoral epiphysis typically presents with the following symptoms
- pain in the groin, inner thigh, knee or hip
- antalgic gait or limp
- limited internal rotation of the hip
- outward turning of the hip, or
- difficulty or inability to bear weight on affected leg.2
Preclinical Data
In a juvenile rat study, epiphyseal growth plate changes were observed in rats treated with selpercatinib. These changes were associated with decreased femur length and reductions in bone mineral density and were not reversible.1
About the LIBRETTO-121 Pediatric Trial
LIBRETTO-121 (NCT03899792) is a multicenter, open-label, phase 1/2 study of selpercatinib (LOXO-292) administered orally to pediatric patients aged 6 months to 21 years with an activating rearranged during transfection (RET) alteration and an advanced solid or primary central nervous system tumor.3,4
About the LIBRETTO-531 Clinical Trial
LIBRETTO-531 is a multicenter, randomized, open-label, phase 3 trial comparing selpercatinib to physician's choice of cabozantinib or vandetanib in patients with metastatic, advanced, kinase inhibitor naïve, RET-mutant medullary thyroid cancer (MTC) (NCT04211337).5,6
Enclosed Prescribing Information
References
1Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Peck DM, Voss LM, Voss TT. Slipped Capital Femoral Epiphysis: Diagnosis and Management. Am Fam Physician. 2017;95(12):779-784.
3Morgenstern D, Casanova M, Van Tilburg C, et al. Safety and efficacy of selpercatinib in pediatric and adolescent patients with RET-altered solid tumors: results from phase 1/2 LIBRETTO-121 study. Presented at: 2024 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, Illinois. Accessed May 31, 2024. https://meetings.asco.org/abstracts-presentations/231047
4A study of oral LOXO-292 in pediatric patients with advanced solid or primary central nervous system tumors (LIBRETTO-121). ClinicalTrials.gov identifier: NCT03899792. Updated March 7, 2024. Accessed May 20, 2024. https://clinicaltrials.gov/ct2/show/NCT03899792
5Wirth LJ, Brose MS, Elisei R, et al. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naïve RET-mutant medullary thyroid cancer. Future Oncol. 2022;18(28):3143-3150. https://doi.org/10.2217/fon-2022-0657
6A study of selpercatinib (LY3527723) in participants with RET-mutant medullary thyroid cancer (LIBRETTO-531). ClinicalTrials.gov identifier: NCT04211337. Updated October 30, 2023. Accessed November 3, 2023. https://clinicaltrials.gov/ct2/show/NCT04211337
Date of Last Review: September 30, 2024