Telix Pharmaceuticals (ASX: TLX) 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 for the preparation of PSMA-PET imaging 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 and GE FASTlab 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 Americans4 and Veterans5, 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 recurrence6. 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
“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,” Dr Christian Behrenbruch, Managing Director and Group CEO of Telix, said.
“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.”
