Radiopharma firm Telix launches new prostate cancer imaging agent Gozellix in US
Radiopharmaceutical firm Telix on Wednesday announced the U.S. launch of its new prostate cancer imaging agent Gozellix.
The PET (positron emission tomography) product is now commercially available through distributors including Cardinal Health, PharmaLogic, Jubilant Radiopharma, and RLS. Gozellix is indicated for the scanning of PSMA (prostate-specific membrane antigen)-positive lesions in men with cancer suspected to have metastasized who are candidates for therapy.
In recent years, PSMA-PET imaging has become the standard of care for staging and identifying recurrence of prostate cancer, Telix noted. However, only a “small fraction” of the 3.4 million men living with the disease in the U.S. have benefited from the technology, partly due to challenges around access and availability.
Melbourne, Australia-based Telix said it hopes to address the issue with recently approved Gozellix, which carries a shelf life of up to six hours. This allows for an extended transportation distance and clinical administration window. Telix estimated that up to 20% of PET scanners in the U.S. are “beyond the reach” of available PSMA imaging agents, “due to distribution efficiency constraints.” The company also has applied for Medicare reimbursement for Gozellix in hospital outpatient settings.
“We are pleased that Gozellix, our next-generation prostate cancer imaging product, is now available coast-to-coast across the United States. Telix is committed to innovation in PSMA imaging, and Gozellix is a result of this focus,” Kevin Richardson, CEO of precision medicine, said in a statement June 11.
This is the second available PSMA PET imaging agent from Telix, following the commercial launch of Illuccix in 2022. The product serves a similar function but with a shorter shelf life, earning $151 million in first-quarter sales this year. Other PSMA PET imaging products on the market include Pylarify from drugmaker Lantheus (the first to gain approval, with sales of over $1 billion last year) and Posluma from Bracco company Blue Earth Diagnostics. Amid the release of these new products, radiology providers saw demand for PET imaging grow 12.2% in 2024, IMV reported Wednesday.
Telix touted the performance of Gozellix, with specificity of 90%. This enables detection of tiny “micrometastases” at PSA levels as low as 0.02 ng/mL. Gozellix can either be centrally produced with a cyclotron or locally prepared via a gallium generator with up to 500mCi of activity, “enabling greater production flexibility and on-demand capacity.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.