Clarity Pharmaceuticals Receives FDA Fast Track Designation for Cu-64 SAR-bisPSMA Prostate Cancer Imaging Agent

Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company focused on innovative cancer diagnostics and treatments, announced that its ⁶⁴Cu-SAR-bisPSMA imaging agent has been granted Fast Track Designation (FTD) by the FDA. The designation applies to the use of the agent in positron emission tomography (PET) imaging for detecting prostate-specific membrane antigen (PSMA)–positive prostate cancer in patients experiencing biochemical recurrence after definitive therapy.

This milestone marks Clarity’s second FTD for ⁶⁴Cu-SAR-bisPSMA, building on the earlier designation for patients with suspected metastasis who are candidates for initial definitive therapy. The designation accelerates the regulatory review process, offering benefits such as frequent communication with the FDA, expedited resolution of development questions, and the ability to submit applications in sections.

Diagnostics in Prostate Cancer

⁶⁴Cu-SAR-bisPSMA leverages a dual PSMA-targeting structure and the extended half-life of copper-64 (12.7 hours) to provide superior imaging capabilities compared with current agents based on gallium-68 or fluorine-18, which have shorter half-lives. These advantages translate to enhanced diagnostic performance, flexible imaging schedules, and broader geographic accessibility. Data from Clarity’s COBRA phase I/II study highlights the ability of ⁶⁴Cu-SAR-bisPSMA to detect lesions as small as 2 mm, significantly outperforming current standards of care.

The COBRA study laid the groundwork for Clarity’s AMPLIFY phase III trial, which will evaluate the agent’s efficacy in approximately 220 participants with rising or detectable prostate-specific antigen (PSA) levels after initial treatment. Results from AMPLIFY are expected to support regulatory approval for the imaging agent. In addition, the co–PSMA investigator–initiated trial aims to compare ⁶⁴Cu-SAR-bisPSMA with the current standard, ⁶⁸Ga-PSMA-11, for identifying recurrent prostate cancer.

Alan Taylor, PhD, executive chairperson of Clarity Pharmaceuticals, emphasized the significance of the FTD in advancing the company’s diagnostic efforts. “This designation highlights the unique opportunity for ⁶⁴Cu-SAR-bisPSMA in this very large market by addressing the limitations of the current-generation diagnostic radiopharmaceuticals and providing patients with prostate cancer with a more accurate diagnosis leading to more optimal treatment options,” Dr. Taylor stated.