FDA Approves Telix NDA for Prostate Cancer Imaging Agent

Telix Pharmaceuticals Limited, headquartered in Melbourne, Australia, has announced a significant milestone in its efforts to enhance prostate cancer diagnostics. The U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for TLX007-CDx, a new cold kit for the preparation of PSMA-PET imaging, designed for prostate cancer evaluation. The Prescription Drug User Fee Act (PDUFA) goal date is set for March 24, 2025. Upon approval, this new kit will allow a PSMA imaging product to be distributed over a much wider geographic area compared to currently approved gallium-68 (68Ga)-based agents.

The innovative properties of TLX007-CDx are specifically developed to facilitate more flexible production. This includes the use of higher activity 68Ga sourced from modern high activity generators and cyclotrons, employing systems such as the ARTMS® QUANTM Irradiation System™ and GE FASTlab™ for both solid and liquid target production. Telix aims to expand patient access to PSMA-PET imaging, leveraging its established nuclear pharmacy distribution partnerships and its commitment to on-time delivery to underserved populations across the United States.

PSMA-PET imaging is recognized as a major advancement in the management of prostate cancer in the U.S. and has become the standard of care, replacing conventional imaging methods such as bone scans and CT scans following initial diagnosis and biochemical recurrence. Despite this progress, only a small fraction of the 3.4 million American men living with prostate cancer have undergone a PSMA-PET imaging scan.

Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, emphasized the significance of this development, stating that the acceptance of the NDA filing is a critical step towards improving access to this advanced imaging technology. He noted the rapid adoption and geographic expansion of PSMA-PET imaging with Telix's first commercial product, Illuccix®. Dr. Behrenbruch expressed optimism about working with the FDA to bring TLX007-CDx to American men suffering from prostate cancer, particularly those in regions with limited access to advanced imaging.

Telix Pharmaceuticals Limited is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals along with associated medical devices. The company operates not only in Australia but also has a presence in the United States, Europe (Belgium and Switzerland), and Japan. Telix is building a portfolio of clinical and commercial stage products aimed at addressing significant unmet medical needs in oncology and rare diseases. The company is listed on the Australian Securities Exchange (ASX: TLX).

Telix's lead imaging product, the gallium-68 (68Ga) gozetotide injection, also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®, has received approval from several regulatory bodies, including the FDA, the Australian Therapeutic Goods Administration (TGA), and Health Canada. No other Telix product has obtained marketing authorization in any jurisdiction.

The development of TLX007-CDx is part of Telix's broader strategy to innovate in the field of prostate cancer diagnostics and improve patient outcomes by making advanced imaging technology more widely accessible. With the FDA's acceptance of the NDA, the company is one step closer to achieving this goal, potentially offering a new standard of care for millions of men living with prostate cancer in the United States.