FDA Grants Fast Track Designation to 64Cu-SAR-bisPSMA

The US Food and Drug Administration recently announced that ⁶⁴Cu-SAR-bisPSMA, from Clarity Pharmaceuticals, received fast-track designation.

⁶⁴Cu-SAR-bisPSMA is for the positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis for patients who are eligible for initial definitive therapy.

“Receiving Fast Track Designation for ⁶⁴Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product,” Clarity Pharmaceuticals’ Executive Chairperson, Dr. Alan Taylor, said. “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.”

Clarity Pharmaceuticals is currently operating 2 trials with separate patient groups involving ⁶⁴Cu-SAR-bisPSMA, including those with prostate cancer who are pre-radical prostatectomy and those with biochemical recurrence (BCR) of disease.

A previous study, the phase 1 PROPELLER trial, found that ⁶⁴Cu-SAR-bisPSMA showed encouraging safety and efficacy results in patients with prostate cancer who had not received radical prostatectomy.

The phase I/II COBRA trial demonstrated that ⁶⁴Cu-SAR-bisPSMA was safe and effective in identifying prostate cancer lesions in patients with BCR.

“We believe that 64Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis. Due to its dual targeting structure, bisPSMA, and the longer half-life of copper-64, enabling next-day imaging, this unique product has shown higher tumor uptake and retention and exhibited a capability of detecting much smaller lesions,” Dr. Taylor said. “The longer half-life of the isotope also translates into a longer shelf-life than currently used diagnostic radiopharmaceuticals, allowing for centralized manufacture and wider distribution, while also supporting flexible patient scheduling.”