FDA approves first commercially available PSMA PET imaging agent for prostate cancer

The U.S. Food and Drug Administration has approved the first and only commercially available PSMA PET imaging agent for prostate cancer, manufacturer Lantheus Holdings announced Thursday morning.

PYLARIFY is a F 18-labeled, prostate-specific membrane antigen targeted positron emission tomography agent used to pinpoint suspected metastasis or recurrence of the disease. North Billerica, Massachusetts-based Lantheus said the product will be immediately offered in parts of the mid-Atlantic and southern regions of the U.S., with rapid expansion over the next six months and broad availability by year’s end.

“The FDA approval of PYLARIFY is a significant milestone for Lantheus and the prostate cancer community in the United States,” Mary Anne Heino, president and CEO of Lantheus, said in a statement. “We believe PYLARIFY represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors, along with patients and their families, can make more informed treatment decisions.”

Among men with localized prostate cancer undergoing treatment, upward of 50% may experience recurrence of the disease within 10 years. This reappearance is typically detected via a rise in prostate-specific antigen levels, but conventional imaging is not able to identify and localize the disease in most cases, the company noted. PYLARFIY targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. It does so by binding to the target, allowing physicians to detect and locate the disease.

FDA approval for the new agent was based on two company-sponsored studies designed to establish its safety and efficacy. Lantheus said such trials demonstrated improvement in specificity and positive predictive value of PYLARIFY PET imaging over conventional imaging in men at risk for metastatic prostate cancer prior to initial therapy. In one investigation, nearly 600 patients with varying states of prostate cancer were exposed to a single dose. Adverse responses were reported in less than 2% of individuals, while a delayed hypersensitivity reaction occurred in just one patient (0.2%).

Axumin is an alternative PET imaging agent for biochemically recurrent prostate cancer. Approved by the U.S. FDA in 2016, the drug uses a different method of action (amino acid transport). 

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