Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020.

Full prescribing information for Retevmo will be posted on Drugs@FDA.

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