Selpercatinib (Retevmo) Converts to Traditional Approval as First Tumor-Agnostic RET Fusion Therapy

The FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and pediatric patients 2 years and older with locally advanced or metastatic solid tumors harboring a RET gene fusion — converting the drug's prior accelerated approval (adults in 2022, pediatric extension 2024) to full approval and making it tissue-agnostic across cancer types rather than limited to specific tumor sites. Efficacy was confirmed in the multicenter LIBRETTO-001 trial, which showed a 47% overall response rate and 24.5-month median duration of response in 75 previously treated RET fusion-positive tumors outside NSCLC and thyroid cancer, supported by earlier positive results in RET fusion-positive lung and thyroid cancers. The approval came two months ahead of the FDA's target action date.