• Clarity Pharmaceuticals receives U.S. FDA Fast Track Designation for 64Cu-SAR-bisPSMA in biochemical recurrence of prostate cancer
• The designation enables accelerated development and review of the product
• 64Cu-SAR-bisPSMA shows improved diagnostic performance, flexible imaging schedule, and broader availability compared to current PSMA PET agents

Clarity Pharmaceuticals (ASX: CU6) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy. This milestone builds on Clarity's earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy. The FTD will enable Clarity to accelerate the development of its comprehensive diagnostic program with this product. The designation paves the way for a faster review process, more frequent communication with the FDA, and the ability to submit completed sections of the application as they are ready, reducing the review time needed to bring this innovative prostate cancer imaging agent to market. The FTD submission highlighted several advantages of 64Cu-SAR-bisPSMA over currently approved PSMA PET agents, including improved diagnostic performance, flexible imaging schedule, and broader availability. The data for this FTD submission was primarily focused on the results of the Phase I/II COBRA study, which showed that next-day 64Cu-SAR-bisPSMA PET imaging can detect lesions as small as 2 mm, compared to the current standard of care PSMA PET agents, which struggle to detect lesions smaller than 5 mm. Clarity is now preparing to commence recruitment for its second registrational trial, AMPLIFY, in the coming months, and the FTD will allow the company to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostic.

Clarity Pharmaceuticals expects the market for first-generation diagnostic PSMA PET to grow from approximately US$2 billion (AU$3.2 billion) in the U.S. alone currently to US$3 billion (AU$4.75 billion) by 2029.

Clarity is fully committed to advancing the development of 64Cu-SAR-bisPSMA, which has the potential to become a best-in-class product that addresses the limitations of current-generation diagnostic radiopharmaceuticals and provides patients with prostate cancer with a more accurate diagnosis leading to more optimal treatment options.