FDA approves new prostate cancer imaging agent with extended shelf life

The U.S. Food and Drug Administration has given the green light to a new PET imaging agent targeted at prostate cancer. 

Telix Pharmaceuticals Limited—an Australia-based radiopharmaceutical company—announced the FDA’s approval of Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection) on Friday. Gozellix is indicated for PSMA-positive lesions in men with metastasis who are candidates for therapy, alonog with those suspected of having disease recurrence based on prostate specific antigen (PSA) levels. 

"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,” Kevin Richardson, chief executive officer of Telix Precision Medicine, said in an announcement. “Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach."

One of the major benefits of Gozellix is its shelf life, which lasts up to six hours. This paves the way for increased access to clinics where prostate PET imaging may not have been available in the past. Gozellix also allows for scalable production and more flexible scheduling. 

Clinical trials involving nearly 1,000 patients have indicated that the imaging agent is well tolerated. Thus far, the most common adverse reactions reported have been nausea, diarrhea and dizziness, though these occurred at a rate of less than 1%. 

The new imaging agent joins Telix’s other PSMA-PET imaging agent, Illuccix. The primary difference between the products is shelf life—Gozellix is safe for use approximately two hours longer than Illuccix. Like Illuccix, Gozellix is expected to be eligible for full reimbursement, with reduced or no out-of-pocket costs for patients.  

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