The U.S. Food and Drug Administration has approved Telix Pharmaceutical’s diagnostic imaging product used during prostate cancer exams, the company announced Monday.
Illuccix is a kit for preparing gallium-68 (68Ga) gozetotide, a contrast material for PSMA-PET scanning. It’s the first commercially available injection of its kind approved by the FDA and should quickly improve patient access to 68Ga-based PSMA-PET, a tool that’s been shown to greatly improve prostate cancer care.
“This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States,” Managing Director and CEO of the firm Christian Behrenbruch said in a statement. “Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the U.S. access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body.”
The FDA’s decision applies to patients with suspected metastases who are also candidates for initial definitive therapy and those with suspected recurrence based on their PSA levels.
Telix said it will be able to provide Illuccix to more than 85% of eligible PET imaging sites within its network of more than 140 nuclear pharmacies across the U.S.
“This product offers a level of flexibility and accessibility to healthcare professionals we really haven’t seen before in this class of products and may help us provide better patient experiences as a result,” Oliver Sartor, MD, medical director at Tulane Cancer Center added Monday.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.