FDA Grants Fast Track Designation to 64Cu-SAR-bisPSMA PET Agent for Prostate Cancer

The emerging positron emission tomography (PET) agent ⁶⁴Cu-SAR-bisPSMA has garnered a fast track designation status from the Food and Drug Administration (FDA).

Separate phase I trials have demonstrated the safety and efficacy of 64Cu-SAR-bisPSMA for the imaging of prostate cancer (PCa) prior to radical prostatectomy and in patients with biochemical recurrence of PCa, according to Clarity Pharmaceuticals, the developer of the PET agent.

In comparative research presented at the 2023 Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference, researchers found that 64Cu-SAR-bisPSMA had a higher detection rate for PCa and a higher median tumor-to-background ratio (TBR) in comparison to ⁶⁸Ga PSMA-11 PET/CT. Clarity Pharmaceuticals noted that current phase III trials are ongoing for ⁶⁴Cu-SAR-bisPSMA.

"We believe that ⁶⁴Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis. 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,” noted Alan Taylor, the executive chairperson for Clarity Pharmaceuticals.