Telix submits NDA for TLX101-CDx

Telix Pharmaceuticals has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its PET radiotracer TLX101-CDx (Pixclara) for imaging brain cancer.

The company is seeking approval for TLX101-CDx for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. The imaging agent targets two membrane transport proteins known as large amino acid transporter 1, and large amino acid transporter 2 (LAT1 and LAT2), which are highly expressed in several types of cancer.

Earlier this year, the FDA granted TLX101-CDx fast-track designation, as well as opened an expanded access program for the imaging agent.