The U.S. Food and Drug Administration (FDA) has approved Gozellix (gallium Ga 68 gozetotide)on March 20, 2025, an advanced radiopharmaceutical developed by Advanced Accelerator Applications, a Novartis company. This innovative diagnostic agent is specifically designed to enhance cancer imaging, particularly for neuroendocrine tumors (NETs) and prostate cancer.
Gozellix functions by binding to somatostatin receptors commonly found on neuroendocrine tumor cells. Once injected, it allows precise tumor visualization through positron emission tomography (PET) scans, improving the accuracy of cancer staging, treatment planning and disease monitoring. For prostate cancer patients, it targets prostate-specific membrane antigens (PSMA), helping detect the extent of cancer spread.
The FDA’s approval is based on clinical trial data showing that Gozellix provides highly sensitive imaging of cancerous lesions, even in cases where traditional imaging methods may fall short. By offering a targeted imaging approach, Gozellix contributes to the growing field of theranostics, where diagnostic agents are paired with targeted therapies to improve cancer care.
With its ability to provide clearer, more detailed imaging, Gozellix represents a valuable tool for oncologists aiming to personalize cancer treatment and improve patient outcomes.
Disclaimer: Patients undergoing cancer imaging should consult with their healthcare provider to understand how radiopharmaceuticals like Gozellix may be used in their diagnostic journey.