Update: 67Cu-SAR-bisPSMA for mCRPC Has Been Fast-Tracked by FDA
In a major advancement for metastatic castration-resistant prostate cancer (mCRPC) treatment, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Clarity Pharmaceuticals’ novel radiopharmaceutical therapy, 67Cu-SAR-bisPSMA(we have already written about this exciting family of compounds). The designation is intended to expedite the development and regulatory review of promising therapies targeting serious medical conditions with unmet needs.
The decision follows encouraging preliminary results from the ongoing SECuRE trial, a Phase 1/2a study assessing the safety and efficacy of 67Cu-SAR-bisPSMA in PSMA-positive mCRPC patients who have undergone prior androgen receptor pathway inhibitor therapy. Initial data indicate a strong safety profile and impressive efficacy, with 73% of trial participants experiencing reductions in prostate-specific antigen (PSA) levels, and 45% achieving PSA reductions greater than 50%.
One of the most striking cases from the trial involved a patient who received two cycles of 8 GBq of 67Cu-SAR-bisPSMA. The patient, who had undergone multiple previous treatments—including androgen deprivation therapy, androgen receptor inhibitors, chemotherapy, and a PARP inhibitor—achieved a complete response following the second dose. Post-treatment scans showed no detectable cancer lesions, and PSA levels dropped to undetectable levels, remaining so for nearly thirteen months.
The patient’s case has sparked excitement in the oncology community as an example of theranostics, a precision medicine approach that combines diagnostic imaging with targeted radiopharmaceutical therapy. The SECuRE trial is also exploring different dosing regimens and potential combination therapies, including the integration of 67Cu-SAR-bisPSMA with enzalutamide to enhance therapeutic outcomes.
Clarity Pharmaceuticals has previously received FDA Fast Track Designation for its diagnostic PET imaging agent, 64Cu-SAR-bisPSMA, further supporting the company’s copper-based theranostic platform as a potential game-changer in prostate cancer treatment. If successful, 67Cu-SAR-bisPSMA could offer a highly targeted, well-tolerated, and effective treatment option for heavily pre-treated mCRPC patients.