Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging[1] 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 (PSA) level.
Gozellix® is a novel product which 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 reliably deliver the product much further from its point of production means Gozellix® can reach PET cameras that are currently not served by any PSMA imaging providers, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S. The innovative formulation, which allows for more scalable production, also has the potential to enhance the efficiency, scheduling flexibility and throughput of scanning clinics.
Gozellix® builds on the success of 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 U.S., 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[2]. However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the U.S. have undergone this type of precision medicine scan[3],[4]. Telix believes Gozellix® will help to address these access issues, as it is expected to be eligible for full reimbursement[5] with reduced or no patient co-insurance, meaning it can reach more patients, particularly in underserved populations.
