New Drug Application for PSMA-PET 'cold kit' could expand access to prostate imaging
Telix Pharmaceuticals Limited has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for a “cold kit” that could expand access to PSMA (prostate specific membrane antigen) PET imaging for suspected prostate cancer.
The Melbourne, Australia-based pharmaceutical company announced the NDA for TLX007-CDx on Monday.
TLX007-CDx is a proprietary kit for the preparation of PSMA-PET imaging said to significantly extend the distribution capabilities of imaging agents. Telix says that the kit will allow for more flexible production of imaging agents, including 68Ga sourced from newer high activity generators and cyclotrons.
With greater distribution capabilities promoting more flexibility in exam scheduling, the hope is that the kit will provide expanded access to PSMA PET imaging, especially among those who are most vulnerable to the effects of prostate cancer.
In a press release, Mike Crosby, founder and CEO of Veterans Prostate Cancer Awareness (VPCa), said that the kit could have a “significant impact” for veterans and those living in rural areas if it receives the FDA’s approval.
“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,” Crosby said. “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.”
Managing Director and Telix Group CEO Christian Behrenbruch, PhD, also commented on the kit’s potential to improve scheduling flexibility.
“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,” Behrenbruch said in the release. “We believe this is particularly important as demand for PSMA-PET imaging is forecast to grow significantly over the coming decade.”
Telix’s PSMA-targeted PET imaging product gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix) was the first of its kind to be approved by the FDA. That approval was granted in December 2020.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.