Sperling Prostate Center

FDA Approves Second Imaging Agent in Less Than 6 Months

Just under six months ago, the FDA approved the first radiopharmaceutical, Gallium-68 PSMA-11, for prostate cancer (PCa) detection by PET-CT scans. Approval meant that this injectable isotope had achieved special status as “a first”. The FDA granted its approval for two purposes:
(a) Suspicion of PCa recurrence after treatment, and
(b)Suspicion of metastasis (spread) at the time of PCa diagnosis.

When Gallium-68 is formulated in a molecular way that can bond with the PSMA (prostate-specific membrane antigen) on the surface of PCa cells, those cells “light up” during a PET scan. It is highly sensitive, enabling doctors to identify the extent and location of even very small tumors that they would not otherwise be aware of through conventional imaging. In turn, it facilitates treatment plans that are more likely to be successful.

A second “first”

There’s only one difficulty with Gallium-68: it’s not yet commercially available so doctors don’t have access to it. However, on May 27, 2021 the FDA approved a second PSMA-seeking isotope called piflufolastat F 18 (18F-DCFPyL, trade name PYLARIFY®). It, too, is a “first” because it’s the first such PCa imaging agent that is now “commercially produced and shipped, which will make it available to any medical facility able to perform PET imaging.”

According to a news release by its manufacturer, Lantheus (North Billerica, MA), it is now offered in mid-Atlantic southern U.S. locations, with national access anticipated by the end of the year. Like its older brother Gallium-68, it too is approved for the detection of recurrence after treatment and metastatic disease.

These two “firsts” are great breakthroughs for PCa patients, and the immediate availability of PYLARIFY sweetens the news. Undoubtedly, more lives will ultimately be saved thanks to those who developed and tested these two radiotracers—and hopefully more are on the way.
NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you have health concerns or questions of a personal medical nature.

NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.

[i] Prostate Cancer Foundation. “Breaking News: FDA Approves a Highly Sensitive Prostate Cancer Imaging Agent.” May 27, 2021. https://www.pcf.org/blog/breaking-news-fda-approves-a-highly-sensitive-prostate-cancer-imaging-agent/

 

About Dr. Dan Sperling

Dan Sperling, MD, DABR, is a board certified radiologist who is globally recognized as a leader in multiparametric MRI for the detection and diagnosis of a range of disease conditions. As Medical Director of the Sperling Prostate Center, Sperling Medical Group and Sperling Neurosurgery Associates, he and his team are on the leading edge of significant change in medical practice. He is the co-author of the new patient book Redefining Prostate Cancer, and is a contributing author on over 25 published studies. For more information, contact the Sperling Prostate Center.

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