FDA grants traditional approval to selpercatinib for MTC with RET mutation

The Food and Drug Administration announced it has granted traditional approval to selpercatinib, or Retevmo, from Eli Lilly, for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer, or MTC, with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. On May 29, 2024, the FDA granted accelerated approval for this indication to pediatric patients 2 years of age and older.