Telix Pharmaceuticals said that the U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) for its TLX007-CDx prostate-specific membrane antigen (PSMA)-PET cold kit for prostate cancer imaging
If approved, the company's new cold kit for the preparation of prostate-specific membrane antigen (PSMA)-PET imaging could enable the use of a PSMA-imaging product across an extended geographic distribution radius compared to currently approved gallium-68 (Ga-68)-based agents, according to Telix.
Through this NDA, Melbourne, Australia-based Telix plans to target underserved populations across the U.S. through its established nuclear pharmacy distribution partnerships and experience, the company said. The PET imaging preparation cold kit is designed to facilitate more flexible production, including with Ga-68 sourced from both newer high-activity generators and cyclotrons powered by ARTMS' Quantm Irradiation System and GE HealthCare's FASTlab solid and liquid target production system, the company said previously.
![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&fit=crop&h=100&q=70&w=100)
![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)
