FDA Approves Gozellix for Advanced PSMA-PET Imaging in Prostate Cancer

The FDA has approved the use of Gozellix, a PSMA-PET imaging agent, to help detect prostate cancer using gallium-68 gozetotide in PSMA-PET scans.

The Food and Drug Administration (FDA) has approved Gozellix (TLX007-CDx), a next-generation prostate-specific membrane antigen (PSMA)–PET imaging agent, for patients with prostate cancer, according to a news release from Telix Pharmaceuticals Limited. This imaging tool is a kit that helps prepare patients for an injection of gallium-68 (⁶⁸Ga) gozetotide injection, which is used in advanced PET scans to detect prostate cancer.

Specifically, once Gozellix is combined with ⁶⁸Ga, the now-FDA-approved imaging agent is used to detect PSMA positive lesions during PET scans in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, as well as those with suspected recurrence based on elevated prostate-specific antigen (PSA) levels, according to the release.

“Securing FDA approval for Gozellix is a major win for [patients with prostate cancer], who gain enhanced access to state-of-the-art ⁶⁸Ga PSMA-PET imaging,” Kevin Richardson, chief executive officer of Telix Precision Medicine, said in the news release. “Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. 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.”

Notably, the FDA approval of Gozellix is supported by data from two trials: the PSMA-PreRP trial and the PSMA-BCR trial, respectively.

Moreover, the safety of Gozellix combined with ⁶⁸Ga was assessed in 960 patients as part of the PSMA-PreRP and PSMABCR studies, with each receiving a single dose. The most common side effects, reported in less than 1% of patients, included nausea, diarrhea and dizziness. Regarding additional drug interactions, androgen deprivation therapy and other treatments that target the androgen pathway, such as androgen receptor blockers, may affect how the agent is absorbed in prostate cancer cells.

What is Gozellix?

The novel agent Gozellix is a product which provides a longer shelf life of up to six hours and an extended distribution radius compared with existing gallium-based imaging products, the press release noted. Because of this, Gozellix has the ability to reliably deliver the product much further from its point of production. Therefore, Gozellix can reach PET cameras that are currently not served by any PSMA imaging providers, in turn, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the United States. This new formulation makes it easier to produce and could help scanning clinics work more efficiently, offer more flexible scheduling and serve more patients.

The release goes on to state that Gozellix builds on the success of Telix’s existing PSMA-PET imaging agent, Illuccix, and will be offered alongside it, giving patients and healthcare providers more options based on individual needs. According to official UChicago Medicine website, PSMA-PET imaging is a diagnostic tool that uses a type of medical imaging called positron emission tomography (PET) to detect prostate cancer anywhere in the body.

In the United States, PSMA-PET imaging has become the standard for detecting prostate cancer after initial diagnosis and when there are signs of recurrence. This advanced imaging is highly accurate and sensitive; however, only a small percentage of the 3.4 million men living with prostate cancer have had access to it. The company, Telix, expects Gozellix to improve availability by qualifying for full reimbursement, with little to no out-of-pocket costs for patients. Therefore, this FDA approval may address this current unmet need and could help expand access, especially for underserved communities.

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