UPDATE: FDA Grants Breakthrough Therapy Designation to ⁶⁴Cu-SAR-bisPSMA for Prostate Cancer Imaging

The FDA granted Breakthrough Therapy designation to ⁶⁴Cu-SAR-bisPSMA, an experimental PSMA-targeted PET imaging agent, for detecting lesions in men with suspected prostate cancer recurrence following a rise in PSA. This represents the first Breakthrough Therapy designation awarded to a PSMA PET imaging agent.

The decision was supported by clinical evidence from the Phase 2 Co-PSMA trial, the Phase 1/2 COBRA trial, and real-world imaging data. In Co-PSMA, previously covered by Prostate Warriors, ⁶⁴Cu-SAR-bisPSMA detected 63 lesions compared with 24 using ⁶⁸Ga-PSMA-11 in 50 patients with biochemical recurrence. Positive scan rates were 78% versus 36%, respectively. These findings suggest improved detection of recurrent disease, particularly where tumor burden is low.

The diagnostic program has also reached another milestone: both Phase 3 registration trials, AMPLIFY for biochemical recurrence and CLARIFY for high-risk prostate cancer before prostatectomy, have completed recruitment. Initial results are expected in the first half of 2027.

Importantly, the same molecular targeting platform is also being investigated therapeutically using copper-67 (⁶⁷Cu-SAR-bisPSMA), a beta-emitting isotope. In the early-phase SECuRE trial, previously reported data from 19 patients treated at the 8 GBq dose level showed a PSA50 response rate of 63%, with several complete responses observed. Unlike ⁶⁴Cu, which is used for imaging, ⁶⁷Cu delivers therapeutic radiation to PSMA-expressing cancer cells. The two isotopes therefore offer a potential diagnostic and therapeutic pairing.

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