PSMA PET 'cold kit' could score FDA approval soon
A new PSMA “cold kit” that experts are hopeful will expand access to prostate cancer therapeutics could be approved early next spring, according to an announcement made by Telix Pharmaceuticals Limited on Wednesday.
The Melbourne, Australia-based pharmaceutical company submitted a New Drug Application for the cold kit, or TLX007-CDx, to the U.S. Food and Drug Administration earlier in May.
The product is a preparation kit for imaging agents used in PSMA-PET exams. It is said to significantly expand the distribution capabilities related to imaging agents—essentially, it expands an agent’s shelf life.
The hope is that these expanded capabilities will also promote greater flexibility in scheduling, thus increasing access to PSMA PET imaging.
The kit’s New Drug Application was approved shortly after it was submitted, and the FDA has since given an approximate PDUFA (Prescription Drug User Fee Act) date of March 24, 2025.
“This filing acceptance is an important step towards further improving equity of access and reinforcing our commitment to innovation in prostate cancer to continue to meet the needs of healthcare professionals and their patients,” Christian Behrenbruch, PhD, managing director and Group CEO of Telix, said in a statement. “We now look forward to working with the FDA to bring TLX007-CDx to American men living with prostate cancer, including those residing in underserved communities and regions where access to state-of-the art imaging remains limited."
PDUFA dates refer to when the FDA estimates the review process of a new drug will be completed. These dates provide drugmakers with a concrete timeline of their product’s path to potential approval. PDUFA dates typically occur 10 months after the FDA accepts a company’s New Drug Application, though some are expedited, and some might require an extension.
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.
Learn more about Telix here.
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.