FDA grants full approval for Retevmo in MTC

On September 27, 2024, the US Food and Drug Administration (FDA) granted traditional approval for US pharma major Eli Lilly’s (NYSE: LLY) Retevmo (selpercatinib) for adult and pediatric patients two years and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

The FDA noted that selpercatinib gained 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 two years of age and older.

In June this year, the FDA also granted full approval of the drug for adult and pediatric patients aged two years 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).