The US FDA has approved the TLX007-CDx kit for preparing gallium-68 gozetotide injection. Radiolabeled TLX007-CDx is a diagnostic agent used in positron emission tomography (PET) to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It is specifically indicated for PET imaging of PSMA-positive lesions in prostate cancer patients suspected of having metastasis and being candidates for initial definitive therapy, as well as those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
Clinical evidence In a clinical trial of 123 patients with suspected metastasis eligible for initial definite therapy, gallium-68 gozetotide PET imaging detected pelvic nodal metastasis with 47% sensitivity and 90% specificity. In another study involving 635 patients with recurrent prostate cancer, the imaging identified at least…
