Telix Debuts Gozellix, its New Imaging Agent for Prostate Cancer, in the U.S.

Telix Pharmaceuticals Limited recently announced the nationwide commercial launch of Gozellix® in the United States. Gozellix is a next-generation PSMA-PET imaging agent for prostate cancer, provided as a kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection.The product is now available across the U.S. through Telix’s select distribution network.

• Gozellix, a PSMA-PET imaging agent, is FDA-approved for detecting PSMA-positive lesions in prostate cancer patients with suspected metastases or recurrence.
• The agent offers a longer shelf life and improved distribution profile compared to previous gallium-68 PSMA-PET imaging agents.

PSMA-PET imaging has become the standard of care in recent years for staging and detecting biochemical recurrence of prostate cancer. Despite this, only a small portion of the 3.4 million men living with prostate cancer in the U.S. have had access to this technology, largely due to challenges related to availability and healthcare access. To help address this gap, Telix has submitted an application for Medicare reimbursement of Gozellix for eligible patients in the hospital outpatient setting.

According to the press release, 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. 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.

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, stated, “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.”