Radiopharm Theranostics has received fast-track designation from the U.S. Food and Drug Administration (FDA) for the development of its F-18 RAD 101 PET brain radiotracer.
F-18 RAD 101 targets fatty acid synthase, a multi-enzyme protein that catalyzes fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastases. The company is conducting a phase IIB trial to evaluate the diagnostic performance of F-18 RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins.
Companies that receive fast-track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval, as well as priority review if relevant criteria are met, the company noted.
