64Cu-SAR-bisPSMA gained FDA fast track status for advanced prostate cancer imaging.
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.
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.
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.