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.
![Pittsburgh Compound B (PiB) PET distribution volume ratio (DVR) images were projected onto fsaverage surfaces from FreeSurfer and surface smoothed, with PiB (amyloid) slope maps created using ordinary least squares regression (time as only factor) and mixed effects models for 154 participants run at each vertex (P < .01; model: longitudinal Geriatric Depression Scale score estimated by amyloid slope × time + [sex + education + age] × time). This map visualizes the results of the linear mixed-effects models (t score of the main variable, amyloid slope × time) such that regions with a greater t score (red) represent areas in which greater depressive symptoms are associated with greater amyloid accumulation (amyloid slope). Anatomical landmarks are provided: L refers to the left hemisphere, R refers to the right hemisphere, and additional labels indicate the anterior and posterior ends of the brain. Images available for republishing under Creative Commons license (CC BY 4.0 DEED, Attribution 4.0 International) and courtesy of JAMA Open Network.](https://img.auntminnie.com/files/base/smg/all/image/2024/08/PET_depression.66cf997f7e441.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
