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

December 2, 2020

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.

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.

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.

“We would like to acknowledge the Clinical Trials Network’s role in initiating an academic multi-center trial that evolved into this bi-center study,” said Thomas Hope, associate professor in residence at UCSF. “We hope that this serves as a model of academic collaboration to bring other radiopharmaceuticals to market.”

The FDA approval included both generator- and cyclotron-produced gallium. Cyclotrons are able to generate more activity and thus produce larger batches of drug. It will also help to ensure consistent availability of the agent should there be a generator shortage in the future.

“PSMA is a highly relevant target for prostate cancer imaging. It is now pretty clear that PSMA PET is currently the most accurate and sensitive imaging modality for prostate cancer staging compared to the other imaging modalities available.” said Jeremie Calais, assistant professor at UCLA and director of the clinical research program of the Ahmanson Translational Theranostics Division. “I truly believe that using 68Ga-PSMA-11 PET will help to improve the care of patients with prostate cancer.”

Currently, FDA-approved 68Ga-PSMA-11 is available only at UCSF and UCLA. The institutions have released exclusivity, allowing for ANDAs  to be filed. 

The FDA press release is available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer.

Click here for helpful information you need to know on the new PSMA PET Landscape.