Clarity Receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA

Clarity Receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA

By, Admin 24 August 2024

Overview

Clarity Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for its 64Cu-SAR-bisPSMA, a diagnostic agent designed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients suspected of having metastasis and who are candidates for initial definitive therapy.

About 64Cu-SAR-bisPSMA

  • 64Cu-SAR-bisPSMA represents a significant advancement in prostate cancer diagnosis. 
  • This innovative product enables next-day imaging and has demonstrated higher tumor uptake and retention, along with the ability to detect much smaller lesions. 

Impact of Longer half Life

  • The longer half-life of copper-64 also results in an extended shelf-life compared to currently available diagnostic radiopharmaceuticals, facilitating centralized manufacturing and broader distribution while supporting more flexible patient scheduling—advantages not offered by gallium-68 and fluorine-18 based diagnostics.

Clinical Program Groups: -

The ongoing clinical program for 64Cu-SAR-bisPSMA includes trials in two key patient groups: 

those with prostate cancer scheduled for radical prostatectomy, and those experiencing biochemical recurrence (BCR) of the disease. 

Phase I PROPELLER Study Results

The completed Phase I PROPELLER study yielded favorable safety and efficacy results in patients prior to radical prostatectomy, leading to the initiation of a registrational Phase III trial, CLARIFY, which is currently recruiting participants.

About Phase I/II COBRA Trial

  • Concurrently, the Phase I/II COBRA trial demonstrated that 64Cu-SAR-bisPSMA is both safe and highly effective in detecting prostate cancer lesions in patients with BCR. Based on the promising outcomes of the COBRA study, Clarity is planning a second registrational Phase III imaging trial. 
  • The FDA’s fast track designation is supported by initial clinical evidence suggesting that 64Cu-SAR-bisPSMA may offer superior lesion detection compared to existing prostate cancer diagnostics.

This designation underscores the potential of 64Cu-SAR-bisPSMA to provide a novel diagnostic solution for prostate cancer patients, addressing the limitations of current-generation diagnostic radiopharmaceuticals.