LOXO ONCOLOGY, INC.

FDA approves selpercatinib (Retevmo) for advanced or metastatic medullary thyroid cancer (MTC) with RET mutation in adults and pediatric patients aged 2 years and older. The approval is based on the LIBRETTO-531 trial, showing selpercatinib's efficacy with progression-free survival (PFS) not reached compared to 16.8 months in the control arm. Selpercatinib's dosing varies by age and body surface area, with reduced severe side effects reported compared to other treatments.