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Retevmo ® (selpercatinib) capsules
40 mg, 80 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What was the incidence of slipped capital femoral epiphysis in pediatric patients taking Retevmo® (selpercatinib) in LIBRETTO-121?
One patient (3.4%) experienced slipped capital femoral epiphysis in the LIBRETTO-121 study.
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%) in patients receiving selpercatinib in LIBRETTO-121 (N=27).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 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 RET alteration and an advanced solid or primary central nervous system (CNS) tumor (NCT03899792).3,4
The LIBRETTO-121 study cohorts are presented in LIBRETTO-121 Study Cohorts .
Abbreviations: CNS = central nervous system; MTC = medullary thyroid cancer; RET = rearranged during transfection.
Key eligibility criteria for study participation include
- advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
- evidence of an activating rearranged during transfection RET gene alteration in the tumor and/or blood
- measurable or non-measurable but evaluable disease
- performance score of ≥50 as assessed by Karnofsky in patients ≥16 years or Lansky in patients ≤15 years
- adequate hematologic, hepatic, and renal function
- ability to receive study drug therapy orally or via gastric access, and
- neurologically stable patients with primary CNS tumors and without a steroid dose increase within the 7 days prior to cycle 1 day 1.3,4
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.
3DuBois SG, Albert CM, Mascarenhas L, et al. A phase 1 study of LOXO-292, a highly selective RET inhibitor, in pediatric patients with RET-altered cancers. Poster presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/177961/poster
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 16, 2024. https://clinicaltrials.gov/ct2/show/NCT03899792
5Morgenstern D, Mascarenhas L, Campbell M, et al. Oral selpercatinib in pediatric patients with advanced RET-altered solid or primary CNS tumors: preliminary results from the phase 1/2 LIBRETTO-121 trial. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology (ASCO Virtual); June 4-8, 2021.https://assets.ctfassets.net/mpejy6umgthp/4wP5dLPZGgDUwbUvZUHDlZ/eb150377b5b4384e3f4cfeedf90b62c4/ASCO2021_DV3441_Morgenstern.pdf. Accessed: May 17, 2024.
Date of Last Review: May 17, 2024