Telix Launches New Prostate Cancer Imaging Agent, Gozellix®, in U.S.

Melbourne (Australia) and Indianapolis, IN (U.S.) | 11 June 2025

Telix today announces that its next-generation PSMA-PET imaging[1] agent for prostate cancer, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), is now commercially available nationally in the United States (U.S.).

Gozellix is available through Telix’s comprehensive network of distribution partners, Cardinal Health, Inc., PharmaLogic Holdings Corp., Jubilant Radiopharma, and RLS Radiopharmacies.

After radiolabelling with 68Ga, Gozellix is indicated for PET[2] scanning of PSMA[3] positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. Gozellix builds on proven diagnostic excellence to provide early and accurate detection of metastases at initial staging, with 90% specificity[4]. This clinical performance enables detection of millimetre-scale micrometastases, at PSA levels as low as 0.02 ng/mL[5]. These valuable insights enable physicians to make more informed clinical decisions.

In recent years, PSMA-PET imaging has become established as the standard of care for staging and identifying biochemical recurrence of prostate cancer[6].However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the U.S. have benefited from this technology, in part due to access and availability challenges[7],[8]. Telix has applied for reimbursement for Gozellix, for Medicare-eligible patients in the hospital outpatient setting[9],[10].

Gozellix’s enhanced formulation, with an extended “hot” shelf-life of up to six hours, offers a greater level of patient access and convenience through an extended transportation distance and clinical administration window. Telix estimates that up to 20% of PET cameras in the U.S. are beyond the reach of currently available PSMA-PET imaging agents due to distribution efficiency constraints[11]. By overcoming this limitation, Gozellix can improve access for prostate cancer patients, regardless of where they live, with greater scheduling flexibility for clinicians and their patients.

Gozellix can be either centrally produced with a cyclotron or locally prepared with a gallium generator with up to 500mCi of activity, enabling greater production flexibility and on-demand capacity. Cyclotron-based production of Gozellix is supported by the ARTMS QUANTM Irradiation System® (QIS®), the market-leading cyclotron solid target irradiation system[12].  

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “We are pleased that Gozellix, our next-generation prostate cancer imaging product, is now available coast-to-coast across the United States. Telix is committed to innovation in PSMA imaging, and Gozellix is a result of this focus. It delivers a new level of flexibility in distribution, production and scheduling, along with the high standard of service and reliability that customers have come to expect from Telix.”

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation

Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be

affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of

metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks

Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Hypersensitivity Reactions to Sulfites

Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS

The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

Please note that this information is not comprehensive.

Please see the Full Prescribing Information here.

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.emailing pharmacovigilance@telixpharma.com.

[1]  Imaging of prostate-specific membrane antigen with positron emission tomography.

[2] Positron emission tomography.

[3] Prostate-specific membrane antigen.

[4] PSMA-PreRP clinical study. ClinicalTrials.gov ID: NCT02919111.

[5] Giesel et al. Eur J Nucl Med Mol Imaging. 2015; Alipour et al. Ther Adv Med Oncol. 2019; Burgard et al. Cancers (Basel). 2023 and Abghari-Gerst et al. J Nucl Med. 2022.

[6]  NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2025

[7] NIH Common Cancer Sites — Cancer Stat Facts. Accessed May 2024.

[8] Company analysis based on proprietary and public domain data.

[9]  Hospital Outpatient Prospective Payment System (HOPPS) patients eligible for reimbursed PSMA-PET scanning. 

[10] Telix has applied for a unique HCPCS code for Gozellix and will also pursue Transitional Pass-through status with Center for Medicare and Medicaid Services (CMS).

[11] Data on File. Distribution Metrics. Telix Pharmaceuticals. 2023.

[12] Type II DMF for gallium-68 chloride – DMF# 035947