FDA Fast Tracks 64Cu-SAR-bisPSMA for Prostate Cancer Imaging

• ⁶⁴Cu-SAR-bisPSMA for PET imaging of patients with prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy has received fast track designation (FTD) from the FDA.
• ⁶⁴Cu-SAR-bisPSMA is a novel PET imaging agent for PSMA-positive prostate cancer.
• The designation allows Clarity Pharmaceuticals to engage in more frequent interactions with the FDA, potentially accelerating the agent’s path to market.

The FDA has granted FTD to ⁶⁴Cu-SAR-bisPSMA, a novel radiopharmaceutical developed for PET imaging of PSMA-positive prostate cancer lesions.¹

This designation is particularly significant for patients with suspected metastatic prostate cancer who are candidates for initial definitive therapy. With this FTD, the availability of this advanced diagnostic tool may be expedited.

"Receiving fast track designation for ⁶⁴Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational phase 3 trial, CLARIFY, and preparing for an end-of-phase meeting with the FDA for a second pivotal phase 3 trial with this product. The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic," Alan Taylor, PhD, Clarity's executive chairperson, said in a press release.

Several key advantages for the development of ⁶⁴Cu-SAR-bisPSMA come with this FTD, including an accelerated path to market as the designation allows for a faster review process. The company will benefit from more frequent and streamlined communication with the FDA, allowing for quicker resolution of development issues and smoother progression through the regulatory process.

3D rendered medically accurate illustration of prostate cancer: © SciePro - stock.adobe.com

The first registrational phase 3 trial, CLARIFY, is currently recruiting patients. Additionally, the company is preparing for an end-of-phase meeting with the FDA for a second pivotal phase 3 trial.

"This designation highlights the potential of ⁶⁴Cu-SAR-bisPSMA to provide a novel diagnostic option for patients with prostate cancer and address the limitations of the current-generation diagnostic radiopharmaceuticals," said Taylor, in the press release.

About 64Cu-SAR-bisPSMA

⁶⁴Cu-SAR-bisPSMA is a novel diagnostic option that has shown superiority vs current-generation radiopharmaceuticals. Preclinical comparisons have demonstrated that ⁶⁴Cu-SAR-bisPSMA exhibits superior tumor uptake compared with PSMA-617. This suggests it may become a best-in-class theranostic agent for patients with prostate cancer.²

In addition to 64Cu-SAR-bisPSMA, the company is also developing ⁶⁷Cu-SAR-bisPSMA for metastatic castrate-resistant prostate cancer. Multiple trials are being conducted to support the registration of 64Cu-SAR-bisPSMA for both preprostatectomy and biochemical recurrence patient populations.

REFERENCES:

1. ​​Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA. News release. Clarity Pharmaceuticals. August 22, 2024. Accessed August 22, 2024. https://tinyurl.com/zpb9fykt

2. Pipeline. Clarity Pharmaceuticals. Accessed August 22, 2024. https://www.claritypharmaceuticals.com/pipeline/sar-bispsma/