FDA accepts Telix's NDA for Pixclara

The U.S. Food and Drug Administration (FDA) has accepted radiopharma company Telix's new drug application (NDA) for TLX101-CDx (Pixclara), an agent for glioma imaging.

The FDA granted application priority review and designated a Prescription Drug User Fee Act (PDUFA) goal date of April 26, 2025, paving the way for a U.S. commercial launch for next year.

Pixclara (F-18 floretyrosine or F-18 FET) is a PET agent that helps characterize progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. FET PET is already included in international clinical practice guidelines for the imaging of gliomas.

Telix is also reviewing the potential use of Pixclara as a companion diagnostic agent for the company's TLX101-Tx, the investigational neuro-oncology drug currently in development. This targets the same amino acid transporter mechanism with therapeutic targeted radiation.