Posted by Michael Wonder on 29 Jan 2020
Lilly receives FDA priority review for the selpercatinib new drug application
29 January 2020 - Eli Lilly announced today that the U.S. FDA has granted priority review for the new drug application for selpercatinib (LOXO-292), for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
The application is based on data from the LIBRETTO-001 Phase 1/2 trial in RET-altered lung and thyroid cancers.
The FDA has filed the application and set a Prescription Drug User Fee Act date in the third quarter of this year.
