15 October 2018 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
This designation supplements the two LOXO-292 breakthrough therapy designations granted in September 2018. The breakthrough therapy designation announced today was also based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial.