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FDA Announces First-Ever Approval of PSMA PET for Prostate Cancer Imaging

68Ga-PSMA-11 PET is indicated for prostate cancer patients with suspected metastasis who are candidates for initial definitive therapy or for those with suspected recurrence based on an elevated serum prostate specific antigen (PSA) level. It has significant potential to improve treatment for many patients, as it can provide earlier information about disease recurrence and can pinpoint the location of lesions. Ga-68-PSMA-11 has been used with good results since a few years in several institutes around the world as investigational or under ‘orphan’ drug category.


On December 1, the U.S. Food and Drug Administration approved Gallium-68 (68Ga) PSMA-11 for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer. It is the first approval for a PSMA PET tracer in the United States.


The approval was granted to the University of California, Los Angeles, and the University of California, San Francisco. Approval followed two prospective clinical trials involving a total of 960 prostate cancer patients. Those participating in the first trial had biopsy-proven cancer and high risk of metastasis; among the patients who proceeded to surgery, those with positive readings in the pelvic lymph nodes on 68Ga-PSMA-11 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology. Patients participating in the second trial had biochemical evidence of recurrent prostate cancer; of those with positive scans, local recurrence of metastasis was confirmed in an estimated 91% of cases. No serious adverse reactions were reported in either trial.


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Source: SNMMI