FDA to open expanded access program for Telix's Pixclara

The U.S. Food and Drug Administration (FDA) has opened an expanded access program for Telix Pharmaceuticals' PET radiotracer TLX101-CDx (Pixclara, F-18 floretyrosine) for imaging progressive or recurring gliomas.

Telix plans to file a new drug application with the FDA for radiotracer in the third quarter of this year, it said.

The FDA uses expanded access programs to enable access to investigational products outside of a clinical trial to patients with life-threatening illnesses for whom there are no comparable or satisfactory alternate options, Telix explained.