The FDA has granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients aged 2 years and older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are radioactive iodine (RAI)-refractory, if RAI is appropriate. Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020.
Efficacy was evaluated in LIBRETTO-001 (ClinicalTrials.gov Identifier:
JUNE 14, 2024