MELBOURNE, Australia , July 24 , 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit ("Kit") for the preparation of PSMA-PET imaging [1] for prostate cancer.
The PDUFA [2] goal date is March 24, 2025 . If approved, the new Kit will enable use of a PSMA imaging product with a considerably extended geographic distribution radius from a nuclear pharmacy compared to currently approved gallium-68 ( 68 Ga) based agents. Its innovative properties are designed to facilitate more flexible production, including with higher activity 68 Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS® QUANTM Irradiation SystemTM [3] and GE FASTlabTM [4] solid and liquid target production system.
Through this NDA, Telix's objective is to further enhance patient access to PSMA-PET imaging and the clinical benefits of 68 Ga imaging to underserved populations across the U.S., using Telix's established nuclear pharmacy distribution partnerships and industry-leading on-time reliability.
PSMA-PET imaging represents a major advancement in prostate cancer management and in the U.S. has replaced conventional imaging methods (bone scan, CT scan) as the standard of care after initial diagnosis and biochemical recurrence [5] .
Despite this major medical advancement.