FDA Approves PET Imaging Product Gozellix for Prostate Cancer, Enhancing Diagnostic Accuracy and Accessibility

Published: 25 Mar 2025

Author: Precedence Research

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TELIX Pharmaceuticals' Gozellix, a new imaging agent for PET indication, was approved by the FDA for evaluating and improving the management of patients with prostate cancer. Gozellix is a proprietary cold kit for the preparation of gallium-68 gozetotide injection, which allows for improved imaging of men with PSMA-positive lesions. The approval is another advance in nuclear medicine to provide access to next-generation prostate cancer imaging.

The indication of Gozellix is for men with suspected metastases from prostate cancer or recurrent prostate cancer based on elevated serum levels of PSA. These further aids the clinician in selecting treatment options.

Enhanced Shelf Life and Distribution

Telix Pharmaceuticals has just approved a new imaging agent for prostate carcinoma called Gozellix, now its shelf life extends up to six hours. This makes the imaging much more available to patients throughout the US, adding that Telix is committed to innovation. The extension facilitates accessing PET imaging to an even broader range of healthcare facilities that were previously underserved by PSMA imaging providers. The FDA approval of Gozellix is a big victory for prostate cancer patients, offering better access to top-notch 68Ga PSMA-PET imaging.

Expanding Access and Affordability

Gozellix is set to be added to Telix's diagnostic agents as a new imaging agent by the company. Complete reimbursement qualification is in view to alleviate or eliminate out-of-pocket expenses for patients. This development is in consonance with the already-existing Illuccix, an imaging agent for prostate cancer detection based on gozetotide, which was approved in December 2021 by the FDA. The addition of Gozellix will be a more individualized imaging option for healthcare professionals to better diagnose prostate cancer quickly and accurately.

Clinical Validation of Gozellix

The safety and efficacy of gallium Ga-68 gozetotide were assessed in human clinical trials in the PSMA-PreRP Trial and the PSMA-BCR Trial. 325 patients with intermediate- to high-risk prostate cancer were part of the trials, with results showing a specificity of 90% and a sensitivity of 47% for detecting pelvic lymph node metastases. These measures yielded a positive predictive value (PPV) of 61% and a negative predictive value (NPV) of 84%. Across varying PSA levels, localization rates were good, where 91% of evaluable patients were confirmed as true positive. Gozellix has a favorable safety profile with a low incidence of adverse events reported; the most common side effects were an episode of nausea, diarrhea, and dizziness.

Future of PSMA-PET Imaging

Telix Pharmaceuticals received FDA approval for Gozellix for primary prostate cancer diagnoses and enhances accuracy, accessibility, and affordability. Telix attempts to enhance accessibility to PSMA-PET imaging through flexible scheduling, accessibility, and excellent 68Ga-based clinical performance. The FDA approval of Gozellix is thus a momentous occasion in the treatment of prostate cancer as it will change the way prostate cancer is diagnosed and monitored, directly affecting patient outcomes and fostering precision medicine. Telix Pharmaceuticals is a great contributor to the innovation of nuclear medicine.