FDA Approves New PSMA Kit, Increasing Access to Ga-68 Prostate Cancer Imaging

December 21, 2021

On December 20, the U.S. Food and Drug Administration approved a new kit for preparation of gallium-68 (68Ga) PSMA-11 injection for PET imaging of PSMA-positive lesions in men with prostate cancer. The approval will make 68Ga PSMA-11 PET imaging more widely available in the United States.

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 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. More information is available in the SNMMI Appropriate Use Criteria for Prostate-Specific Membrane Antigen (PSMA) PET Imaging and the NCCN Clinical Practice Guidelines for Prostate Cancer.

The FDA first approved 68Ga-PSMA-11 PET for prostate cancer imaging in December 2020, but it was available only through the University of California, Los Angeles, and the University of California, San Francisco. FDA approval of the new kit (Illuccix; Telix) will improve access to the imaging for patients across the country.

The kit will be available via Cardinal Health and PharmaLogic.