PSMA PET Prep Product Gozellix Garners FDA Approval

The Food and Drug Administration (FDA) has approved Gozellix® (TLX007-CDx), a new preparation kit for the PSMA PET agent gallium-68 (68Ga) gozetotide.

After radiolabeling with 68Ga, Gozellix is indicated for PSMA PET imaging of men with suspected metastasis of prostate cancer (PCa), according to Telix Pharmaceuticals, the developer of Gozellix. The company said Gozellix is also approved for PSMA PET imaging in cases of suspected PCa recurrence based on elevated prostate-specific antigen (PSA) level.

Telix Pharmaceuticals noted that key advantages with Gozellix include a longer shelf life (up to six hours) in comparison to other gallium-based PSMA PET products. An extended distribution radius may enable the use of Gozellix in PET scanning for areas not being served by other PSMA imaging providers, according to the company.

(Editor’s note: For additional content on prostate cancer imaging, click here.)

Emphasizing the scalable production capability with Gozellix, Telix Pharmaceuticals suggested the product facilitates flexibility with scheduling and efficiency of PSMA PET scanning, bolstering access to the imaging technology for patients with prostate cancer.

“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,” noted Kevin Richardson, the chief executive officer for Telix Precision Medicine. “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.”