Telix Pharmaceuticals  announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX007-CDx, a new and proprietary cold kit ("Kit") for the preparation of PSMA-PET imaging^[1] for prostate cancer.

Subject to regulatory approval, this Kit will enable use of a PSMA imaging product with a considerably extended distribution profile compared to currently approved gallium-68 (⁶⁸Ga) PSMA-PET imaging agents. The Kit's innovative properties are designed to facilitate more flexible production, including with ⁶⁸Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS® QUANTM Irradiation System™^[2] and GE FASTlab™^[3] solid and liquid target production system. The Company believes this will further expand the availability, distribution and scheduling flexibility of PSMA-PET imaging.

Despite the commercial availability of PSMA-PET imaging agents in the U.S., access is still severely limited for underserved patient demographics in many regions. This most notably impacts African Americans^[4] and Veterans^[5], who already experience much higher incidence rates of prostate cancer, including late-stage presentation, than the general population.

Telix's new investigational prostate cancer imaging product is intended to address the unmet needs of patients, referrers and health care professionals, and expand patient reach 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^[6]. Despite this major medical advancement, only a relatively small fraction of the 3.4 million men living with prostate cancer in America have undergone a PSMA-PET imaging scan^[7],[8].

Mike Crosby, Founder and CEO Veterans Prostate Cancer Awareness (VPCa) stated, "Even in some of the most populous U.S. states, access to PSMA-PET imaging can be highly variable. Patients in rural areas of the country often bear the extra burden of long-distance travel, extended time off work, and increased out of pocket costs to access medical services. All of these factors contribute to 'financial toxicity' as well as challenges in accessing proper care commonly associated with cancer treatment. If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients' survival."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix stated, "The scheduling flexibility and accessibility, along with the excellent clinical performance of ⁶⁸Ga-based PSMA-PET imaging, has enabled Telix to drive rapid geographic expansion of PSMA-PET imaging with our first product Illuccix®. A core value of our Company is the commitment to improving access to medicine and delivering clinical utility that will benefit patients, very much reflected in the development of this exciting new product. We believe this is particularly important as demand for PSMA-PET imaging is forecast to grow significantly over the coming decade."