Clarity Pharmaceuticals (ASX:CU6) has been granted FDA Breakthrough Therapy designation for 64Cu-SAR-bisPSMA for positron emission tomography of PSMA-positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen level, marking the first such designation in the history of PSMA PET imaging, the company disclosed on 12 November 2026.

Key Points

  • FDA granted Breakthrough Therapy designation to 64Cu-SAR-bisPSMA for PSMA PET imaging in biochemical recurrence of prostate cancer.
  • The designation is supported by data from the Phase II Co-PSMA trial, Phase I/II COBRA trial, and real-world evidence.
  • Two registrational Phase III trials — AMPLIFY and CLARIFY — have completed recruitment and are in patient follow-up, with topline data anticipated in the first half of CY2027.
  • Breakthrough Therapy designation benefits include all Fast Track designation features, intensive FDA guidance, and organisational commitment from senior FDA managers for a proactive, collaborative review.

FDA Breakthrough Therapy Designation Details

The Breakthrough Therapy designation is a 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 on a clinically significant endpoint. The designation provides all Fast Track designation features, intensive guidance on an efficient drug development program, and organisational commitment from the FDA involving senior managers for a more proactive, collaborative, cross-disciplinary review. Breakthrough Therapy designation is also described in the filing as a positive indicator of potential eligibility for Priority Review, which can be requested at the time of a New Drug Application submission.

Supporting Clinical Trial Data for the Designation

The FDA Breakthrough Therapy designation was supported by data from the Phase II Co-PSMA trial, Phase I/II COBRA trial, and real-world evidence, which the filing states collectively indicate enhanced diagnostic performance of 64Cu-SAR-bisPSMA over standard-of-care PSMA PET in patients with biochemical recurrence of prostate cancer. According to the filing, the Co-PSMA trial had participants with a median PSA level of 0.43 ng/mL and a 68Ga-PSMA-11 detection rate of 36%, while the detection rate for 64Cu-SAR-bisPSMA in the same patient group was more than double at 78%. A patent for the composition of matter was filed in June 2018, providing patent protection until at least 2038.

Phase III Trial Status and Anticipated Topline Data

Clarity is currently progressing two registrational Phase III trials with 64Cu-SAR-bisPSMA: AMPLIFY (NCT06970847) and CLARIFY (NCT06056830). Both trials have successfully completed recruitment and are now in patient follow-up. Topline data from both pivotal trials are anticipated to be released in the first half of calendar year 2027. The final study results from both trials are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent — in prostate cancer patients prior to undergoing definitive therapy for CLARIFY, and with biochemical recurrence for AMPLIFY.