FDA grants traditional approval to selpercatinib for RET fusion-positive solid tumors

The Food and Drug Administration has granted traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors, according to an FDA notice. FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors.¹ The notice does not specify a date for this action or provide details on the trial data, dosing, or clinical endpoints that supported the decision. It is not stated whether this traditional approval represents a conversion of a prior accelerated approval or a separate regulatory action.

Selpercatinib is marketed as Retevmo by Eli Lilly and Company. On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib for pediatric patients two years of age and older with RET-altered metastatic thyroid cancer or solid tumors.²

That pediatric approval addressed a population with tumors driven by RET gene alterations, spanning both metastatic thyroid cancer and other solid tumor types. No further details on trial data, dosing, or any confirmatory study requirements tied to the pediatric accelerated approval were included in that document.

Together, the two FDA actions reflect regulatory decisions for selpercatinib across different patient populations, one covering adults with locally advanced or metastatic RET fusion-positive solid tumors under traditional approval, and the other covering pediatric patients with RET-altered metastatic thyroid cancer or solid tumors under accelerated approval. The documents provided do not clarify how these two approval pathways relate to one another or whether additional confirmatory trials are required to maintain either approval status.