FDA Grants Breakthrough Therapy Designation to 64Cu-SAR-bisPSMA for Prostate Cancer PET Imaging: 78% Detection vs 36% in Trial
Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company based in Sydney, Australia, announced on November 12 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its imaging agent 64Cu-SAR-bisPSMA for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum PSA levels after definitive treatment. It is the first Breakthrough Therapy designation ever granted in PSMA PET imaging.
Breakthrough Therapy designation is an FDA process designed to expedite the development and review of drugs intended to treat a serious condition where preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy, and it brings intensive FDA guidance and a collaborative review process. The designation was supported by data from the Phase II Co-PSMA trial, the Phase I/II COBRA trial and real-world evidence, which collectively indicate enhanced diagnostic performance of 64Cu-SAR-bisPSMA over standard-of-care PSMA PET in patients with biochemical recurrence of prostate cancer.
In the Co-PSMA trial, 64Cu-SAR-bisPSMA was compared head-to-head with the standard agent 68Ga-PSMA-11 in 50 patients with biochemical recurrence after radical prostatectomy: the proportion of participants with a positive scan was 78% versus 36%, total lesions detected were 63 versus 24, the mean number of lesions per participant was 1.26 versus 0.48, and the true positive rate was 71% versus 29%. The agent had previously received two FDA Fast Track designations.
Clarity is progressing two registrational Phase III trials, AMPLIFY and CLARIFY, both of which have completed recruitment and are in patient follow-up. Topline data from both trials are anticipated in the first half of 2027 and are intended to support an FDA application for approval. Executive Chairperson Alan Taylor said the FDA's award of the first Breakthrough Therapy designation in the history of PSMA PET imaging highlights both the unmet need for more accurate detection of recurrent prostate cancer lesions and the significance of the data generated to date.
The American Cancer Society estimates about 333,830 new cases of prostate cancer in the United States in 2026 and around 36,320 deaths from the disease. A Breakthrough Therapy designation is not a marketing approval: whether the agent is ultimately approved will depend on the Phase III results and the FDA's full review.
Source: Clarity Pharmaceuticals
Published by GSM · USA (original Chinese edition)
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