Emerging PET Agent Garners Second FDA Fast Track Designation for Prostate Cancer Imaging

The prostate-specific membrane antigen positron emission tomography (PSMA PET) agent ⁶⁴Cu-SAR-bisPSMA has now been granted a second fast track designation by the Food and Drug Administration (FDA) for prostate cancer (PCa) imaging.

The PET agent’s latest FDA fast track designation, for biochemical PCa recurrence in patients who have had definitive therapy, comes five months after the initial fast track designation for suspected metastasis in patients who are candidates for definitive PCa treatment, according to Clarity Pharmaceuticals, the developer of ⁶⁴Cu-SAR-bisPSMA.

"Receiving the second (fast track designation) for ⁶⁴Cu-SAR-bisPSMA and well within the 60-day period following our application submission, reserved by the U.S. FDA for review, is yet another significant milestone in our bisPSMA program,” noted Alan Taylor, Ph.D., the executive chairperson of Clarity Pharmaceuticals. “This highlights the high unmet need for novel diagnostics in prostate cancer and the high quality of data we presented to the FDA.”

Emphasizing the increased uptake of ⁶⁴Cu-SAR-bisPSMA in PCa lesions, Clarity Pharmaceuticals noted that recent research has demonstrated the ability of ⁶⁴Cu-SAR-bisPSMA to diagnose recurrent lesions in the 2 mm range months before detection by other PSMA PET agents.