The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Clarity Pharmaceuticals’ copper-64 (Cu-64) SAR-bisPSMA radiopharmaceutical agent
The agent is indicated for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels.
The company highlighted data from the phase II Co-PSMA and phase I/II Cobra trials, as well as real-world evidence, in helping gain this designation. In Co-PSMA, a head-to-head comparison in patients with a median PSA level of 0.43 ng/mL, Cu-64 SAR-bisPSMA had a detection rate of 78%, compared with 36% for gallium-68 (Ga-68) PSMA-11. Cu-64’s 12.7-hour half-life allows imaging up to 30 hours after injection, the company said.
Clarity has completed recruitment for two phase III trials of the agent, Amplify and Clarify, which are evaluating its use in patients with biochemical recurrence and before definitive therapy, respectively. Topline data from both trials are expected in the first half of 2027, Clarity said.
