FDA Grants Breakthrough Status to Cu-64 SAR-bisPSMA

The imaging agent targets prostate cancer recurrence, with two Phase III trials progressing toward topline data.

Updated on Nov. 12, 2026 in Cancer

FDA Grants Breakthrough Status to Cu-64 SAR-bisPSMA

Clarity Pharmaceuticals received Breakthrough Therapy designation from the U.S. Food and Drug Administration for Cu-64 SAR-bisPSMA, a PET imaging agent for detecting PSMA-positive lesions in men with suspected prostate cancer recurrence based on elevated PSA. Clarity is also progressing two registrational Phase III trials, AMPLIFY and CLARIFY.

Why it matters

Current FDA-approved PSMA PET agents often miss metastatic disease, particularly in patients with small-volume disease or lower PSA levels. Fewer than half of Breakthrough Therapy requests are granted, and the designation provides intensive FDA guidance and a collaborative review process.

In the Phase II Co-PSMA trial, Cu-64 SAR-bisPSMA detected lesions in 78% of patients versus 36% for 68Ga-PSMA-11 in a comparable group, with a median PSA of 0.43 ng/mL. Results from the pivotal AMPLIFY and CLARIFY trials remain unreported.

The players

Clarity Pharmaceuticals

An Australian clinical-stage radiopharmaceutical company developing diagnostic and therapeutic agents that target prostate-specific membrane antigen (PSMA) in cancer.

U.S. Food and Drug Administration

The federal agency responsible for regulating drugs, biologics and medical devices in the United States, including granting Breakthrough Therapy designation to accelerate development of promising treatments.

The details

The FDA decision was supported by data from the Phase II Co-PSMA trial and the Phase I/II COBRA trial, along with real-world evidence. The designation covers PET imaging of PSMA-positive lesions in men with suspected prostate cancer recurrence.

Breakthrough Therapy designation was announced in November 2026.
Topline data from the AMPLIFY and CLARIFY trials are expected in the first half of 2027.

Health Landscape

Breakthrough Therapy designation, created under the 21st Century Cures Act, is typically reserved for therapies rather than diagnostic imaging agents, making this designation for a PET tracer a notable extension of the program. The move reflects growing regulatory attention to improving how prostate cancer recurrence is detected, not only how it is treated.

For men with suspected prostate cancer recurrence, a more sensitive imaging agent could help identify disease that current PSMA PET scans miss, potentially informing treatment decisions. Patients should discuss with their oncologist whether emerging imaging options may become relevant to their care once data are available.

The takeaway

Breakthrough designation signals regulatory confidence in better imaging for recurrent prostate cancer, but patients and clinicians should await the 2027 pivotal trial results before expecting changes in standard practice.