FDA Approves TLX007-CDx Kit
The FDA has approved the next-generation prostate-specific membrane antigen (PSMA)–PET imaging agent TLX007-CDx, a kit for the preparation of gallium-68 (68Ga) gozetotide injection (Gozellix) for use in PET scanning of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
The approval is supported by data from the PSMA-PreRP trial (NCT03368547 and NCT02919111) and the PSMA-BCR trial (NCT02940262 and NCT02918357) for the initial definitive therapy and PSA recurrence indications, respectively. Notably, both studies evaluated another formulation of 68Ga gozetotide.
“Securing FDA approval for Gozellix is a major win for [patients with] prostate cancer, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging," Kevin Richardson, chief executive officer of Telix Precision Medicine, stated in a news release. "Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. 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.”
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