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Telix Pharmaceuticals has submitted a new drug application to the United States Food and Drug Administration for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.
Telix said subject to regulatory approval, the kit will enable use of a PSMA imaging product with a considerably extended distribution profile compared to the currently approved gallium-68 (68Ga) PSMA[1]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 limited for certain patient demographics – notably African Americans – in many regions.
Higher incidents of prostate cancer, including late stage presentation. are being detected in African Americans than the general population, and Telix said its 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.
Telix holds the conviction that 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 advancement, only a relatively small fraction of the 3.4 million men living with prostate cancer in America have undergone a PSMA-PET imaging scan7,8 .
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.
Telix shares were up 2.3% at $15.82 in mid-morning trade.
