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Breaking News: Kit for PSMA PET imaging agent gains FDA approval

December 20, 2021

The highly sensitive prostate cancer diagnosis scan called PSMA PET imaging will become more widely available in the U.S. following a new FDA approval.

Today, the FDA approved a kit for the production of the imaging agent 68Ga-PSMA-11 (trade name Illuccix®). 68Ga-PSMA-11 PET was the first type of PSMA PET imaging to gain FDA approval in December, 2020, initially at two centers in California. Going forward, this agent is expected to become available more broadly in the U.S. The kits will be distributed to a network of radiopharmacies that can manufacture 68Ga-PSMA-11, located across the country. From there, it will be delivered for use in PET imaging centers.

68Ga-PSMA-11 is approved for patients with prostate cancer 1) with suspected metastasis who are candidates for initial definitive therapy (i.e., newly diagnosed with high-risk disease) and 2) who previously had their prostate cancer treated, and are now seeing their PSA rise, in order to determine if and where they have metastases.

PSMA is a protein that is present in large amounts on the surface of prostate cancer cells, but is not present on most normal organs. Thus, it makes for an excellent imaging “target.” A small chemical that can bind to PSMA anywhere in the body is attached to a radioactive element (Gallium-68). Once injected into the patient, 68Ga-PSMA-11 travels to sites of prostate cancer and binds to PSMA. The Gallium-68 can be seen on a PET imaging scan. Compared with standard imaging, a PSMA PET scan can detect prostate cancer metastases earlier, when they are much smaller, which may help to improve treatment of patients with prostate cancer.

With this approval, patients and their doctors nationwide now have the option of two different PSMA PET imaging agents; the other is 18F-DCFPyL (trade name PYLARIFY). These agents can be considered interchangeable; in most cases, patients who are getting a PSMA PET scan can opt for the one that is most readily available to them.

Since 1993, PCF has funded critical and foundational PSMA research that established this revolution in PSMA-targeted imaging and therapeutics. Read more on 68Ga-PSMA-11 here and the history of PSMA research here.