The Food and Drug Administration said it granted accelerated approval to Eli Lilly’s selpercatinib, named Retevmo, for pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, advanced or metastatic thyroid cancer with a RET gene fusion, and locally advanced or metastatic solid tumors with a RET gene fusion. This is the first FDA approval of a targeted therapy for pediatric patients less than 12 years of age with RET alterations. Selpercatinib was previously granted accelerated approval for the thyroid cancer indications in adults and pediatric patients 12 years of age and older.
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