The US Food and Drug Administration (FDA) has approved Telix’s new drug application (NDA) for Gozellix (TLX007-CDx) for prostate cancer detection.
Gozellix is a new-generation prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging agent.
The approval allows Gozellix, once radiolabelled with gallium-68 (⁶⁸Ga), to be used in PET scans to identify PSMA-positive lesions in men with suspected metastatic prostate cancer who are candidates for definitive therapy. It also applies to those with suspected recurrence based on elevated prostate-specific antigen (PSA) levels.
Gozellix introduces an extended shelf life of up to six hours, offering a longer distribution radius compared to existing gallium-based imaging agents.
The expanded reach enables access to PET cameras in locations currently underserved by PSMA imaging providers. The formulation also supports increased production scalability, which could enhance scheduling flexibility and improve the efficiency of scanning clinics.
Telix will offer Gozellix alongside its first-generation PSMA-PET imaging agent, Illuccix, providing healthcare providers with additional options tailored to patient needs.
PSMA-PET imaging is widely recognised as the standard of care for prostate cancer detection in the US following initial diagnosis and biochemical recurrence. Despite this, only a limited proportion of the estimated 3.4 million men living with prostate cancer in the US have undergone such scans.
Telix anticipates that Gozellix’s eligibility for full reimbursement, with reduced or no patient co-insurance, will improve accessibility, particularly for underserved patient populations.
Telix precision medicine CEO Kevin Richardson said: “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. 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.”
Separately, Telix has announced that its Illuccix prostate cancer imaging agent has been granted marketing authorisation by the Medicines Evaluation Board (MEB) in the Netherlands. This approval allows the use of Illuccix for detecting and localising PSMA-positive lesions in adults with prostate cancer, expanding access to PET imaging with a clinically validated gallium-based radiopharmaceutical.
Illuccix, following radiolabelling with gallium-68, is indicated in the Netherlands for multiple clinical settings, including primary staging of high-risk prostate cancer prior to curative therapy and detection of suspected recurrence in patients with rising PSA levels post-treatment.
It is also used for the identification of PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) in cases where PSMA-targeted therapy is suitable.
