Shots:

• The approval is based on two prospective studies assessing Ga 68 PSMA-11 in 960 men with prostate cancer. The first trial enrolled 325 patients & the second trial enrolled 635 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans and who had rising serum PSA levels after initial prostate surgery or radiotherapy
• 74% of patients had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one body region
• Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an IV injection. The approval is granted to the University of California

 ­ Ref: PRNewswire | Image: FDA