FDA Approves a Highly Sensitive Prostate Cancer Imaging Agent

On May 26th, the FDA approved another highly sensitive imaging compound specifically for prostate cancer called 18F-DCFPyL. This is the second such approval in less than six months; in December 2020, the FDA approved 68Ga-PSMA-11 PET (gallium-68 PET scan). These pioneering new scanning tools will revolutionize prostate cancer detection. Both imaging agents are used to “light up” PET scans to help doctors find smaller tumors earlier.

Both compounds are part of a new type of scanning technology called PSMA PET imaging. 68Ga-PSMA-11 and 18F-DCFPyL (or PyL for short) are radioactive tracer molecules designed to bind to PSMA that doctors can use to “light up” PET scans in regions that contain cancer. PSMA (“Prostate Specific Membrane Antigen”) is a protein found on the surface of prostate cancer cells. This new technology is more sensitive than conventional imaging (such as CT and bone scans) in finding areas of prostate cancer in the body. Having more complete and accurate information about where cancer is located can help doctors make better treatment plans. Finding metastases earlier, when they are much smaller, will have a significant impact for patients.

PyL PET imaging is approved for two types of patients with prostate cancer: 1) those with suspected metastasis who are candidates for initial definitive therapy (e.g., newly diagnosed with high-risk disease) and 2) those with suspected recurrence based on elevated PSA level (e.g. who previously had their prostate cancer treated, and are now seeing their PSA rise, in order to determine if and where they have metastases).

The main difference between PyL (trade name: PYLARIFY®) and 68Ga-PSMA-11 (approved in December, 2020) is that PyL can be commercially produced and shipped, which will make it available to any medical facility able to perform PET imaging. Currently the gallium-68 scan is only available in Los Angles, and San Francisco. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. The PyL scan from Progenics and Lantheus hopefully will be widely available throughout the US by the end of 2021.

For more details, see the following post from the Prostate Cancer Foundation.

For a great article on PyL PSMA PET imaging, its develoment and use in dedecting small areas of cancer, see the following link.

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