'Game changer' prostate imaging agent granted FDA's Fast Track designation

A new prostate cancer imaging agent has been given the U.S. Food and Drug Administration’s Fast Track designation. 

Clarity Pharmaceuticals made the announcement regarding 64Cu-SAR-bisPSMA on Thursday. Based in New South Wales, Australia, the clinical stage radiopharmaceutical company specializes in the development of theranostic products. 

Their latest PET agent was developed for men with prostate-specific membrane antigen (PSMA) positive lesions who have suspected metastasis and are candidates for initial definitive therapy. It is clinically indicated for men who have not undergone radical prostatectomy and those with biochemical recurrence of their cancer.  

In both patient populations, clinical trials have demonstrated that the agent is safe and effective and offers superior prostate lesion detection in comparison to other existing radiopharmaceuticals.  

Because of its specialized chemical makeup, Clarity Executive Chairperson Alan Taylor, PhD, said that the imaging agent could be a “game changer” for the diagnosis of prostate cancer. 

“Due to its dual targeting structure, bisPSMA, and the longer half-life of copper-64, enabling next-day imaging, this unique product has shown higher tumor uptake and retention and exhibited a capability of detecting much smaller lesions,” Taylor explained in an announcement on the designation. “The longer half-life of the isotope also translates into a longer shelf life than currently used diagnostic radiopharmaceuticals, allowing for centralized [manufacturing] and wider distribution, while also supporting flexible patient scheduling.” 

These features address some of the issues associated with other agents containing gallium-68 and fluorine-18.  

The FDA’s Fast Track designation is granted to expedite the review of drugs that address an unmet clinical need. It is often given to drugs that have shown the potential to outperform other similar products. The designation allows for more streamlined communication between the FDA and drug developers during the approval process and reduces the amount of time needed to review products. 

Taylor said the designation marks a “significant milestone” for the imaging agent, especially as it heading into additional phases of clinical trials. 

“Clarity is committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management,” Taylor said.