Telix Pharmaceuticals Limited announces that its next-generation PSMA-PET imaging agent for prostate cancer, Gozellix (kit for the preparation of gallium-68 gozetotide injection), is now commercially available nationally in the United States.
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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 PET2 scanning of PSMA3 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% specificity4. This clinical performance enables detection of millimetre-scale micrometastases, at PSA levels as low as 0.02 ng/mL5. 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 cancer6. 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 challenges7,8. Telix has applied for reimbursement for Gozellix, for Medicare-eligible patients in the hospital outpatient setting9,10.
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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 constraints11. 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®, the market-leading cyclotron solid target irradiation system12.
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.”
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Source – GlobeNewswire
