Melbourne & Indianapolis, March 21, 2025 – Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has secured FDA approval for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer. This milestone expands Telix’s radiopharmaceutical portfolio and enhances access to high-precision imaging for prostate cancer patients across the U.S.
What Makes Gozellix® a Game-Changer?
Gozellix® (TLX007-CDx) is designed for PSMA-positive lesion detection in men with suspected metastasis or prostate cancer recurrence. The major breakthrough? Extended shelf life and a wider distribution radius, overcoming existing logistical limitations of gallium-based imaging agents.
With a six-hour shelf life, Gozellix® can be transported farther, reaching clinics and PET scanners previously underserved by PSMA imaging providers. This means more men across the U.S. will gain access to cutting-edge PSMA-PET imaging, particularly in remote and under-resourced areas.
Boosting Efficiency for Imaging Centers
Beyond patient access, Gozellix® improves clinic operations:
- More scalable production, allowing for better scheduling flexibility.
- Higher throughput, enabling clinics to serve more patients efficiently.
- Anticipated full reimbursement, with minimal or no patient co-insurance, further reducing barriers to adoption.
Building on the Success of Illuccix®
Gozellix® follows in the footsteps of Illuccix®, Telix’s first-generation PSMA-PET imaging agent, which has already set the standard in prostate cancer imaging. Now, clinicians and patients have an expanded choice, selecting the imaging agent that best fits their needs.
Why This Matters
Prostate cancer is the most common cancer among American men, with 3.4 million currently diagnosed. While PSMA-PET imaging is now the gold standard, only a small fraction of patients have access to this level of precision medicine. Gozellix® aims to change that.
CEO’s Take on the Milestone
Kevin Richardson, CEO of Telix Precision Medicine, stated:
“FDA approval for Gozellix® is a major win for prostate cancer patients. This innovation enhances access to state-of-the-art imaging and reflects our commitment to continuous improvement. With Gozellix®, we are expanding PSMA-PET imaging availability, ensuring more American men can benefit from precision medicine.”
What’s Next?
With FDA approval secured, Telix is set to launch Gozellix® across the U.S., helping more patients receive accurate, timely, and life-changing imaging.
