The product provides a shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products.
Telix Pharmaceuticals Ltd announced that the US Food and Drug Administration (FDA) has approved its New Drug Application for Gozellix, its next-generation prostate-specific membrane antigen positron emission tomography (PSMA-PET) imaging agent for prostate cancer.
Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen level.
Gozellix is a novel product that provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products. The ability to deliver the product further from its point of production means Gozellix can reach PET cameras that are currently not served by any PSMA imaging providers. According to the company, the formulation, which allows for more scalable production, also has the potential to enhance the efficiency, scheduling flexibility, and throughput of scanning clinics.
Second-Generation Agent Aims to Expand Access to PSMA-PET Imaging
Gozellix builds on Telix’s established PSMA-PET imaging agent, Illuccix, and will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs.
In the US, the accuracy and sensitivity of PSMA-PET imaging means it has become the standard of care for prostate cancer imaging after initial diagnosis and biochemical recurrence. However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the US have undergone this type of precision medicine scan. Telix believes Gozellix will help to address these access issues, as it is expected to be eligible for full reimbursement, with reduced or no patient co-insurance.
“Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging,” says Kevin Richardson, chief executive officer of Telix Precision Medicine, in a release. “…With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service, and flexibility that customers have come to expect from Telix.”
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