Selpercatinib previously received accelerated approval for patients aged 12 years and older in 2020 and was extended to younger patients in May 2024, according to a news release from the agency.
The approval was based on the Libretto-531 study, which showed significant efficacy in adults and adolescents. This was a randomized trial, with patients receiving selpercatinib showing superior progression-free survival compared to those treated with cabozantinib or vandetanib.