Clarity Receives Approval for Cu-67 SAR-bisPSMA in Prostate Cancer
Wednesday, February 19, 2025
Clarity Pharmaceuticals has announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA.
Prostate cancer is the second most commonly diagnosed cancer in men worldwide and ranks as the fifth leading cause of cancer-related deaths among men. In the United States, it is the second leading cause of cancer death in men. According to the American Cancer Society, an estimated 313,780 new cases of prostate cancer are expected to be diagnosed in 2025, with approximately 35,770 deaths anticipated from the disease.
SAR-bisPSMA gets its name from the term "bis," highlighting its innovative design, which connects two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology.
This technology securely traps copper isotopes within a cage-like structure called a chelator, preventing leakage into the body—an issue seen with other commercially available chelators. SAR-bisPSMA is a Targeted Copper Theranostic (TCT), designed for both imaging and treatment.
This designation applies to adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously undergone androgen receptor pathway inhibition (ARPI) treatment.
This milestone builds on Clarity’s two prior FTDs for the diagnostic agent 64Cu-SAR-bisPSMA in patients with suspected prostate cancer metastasis and biochemical recurrence (BCR) following definitive therapy.
These approvals reinforce the quality of data generated on 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA in addressing critical unmet medical needs in prostate cancer.
The trial is currently progressing through the highest dose cohort (12 GBq multi-dose). The largest PSA reduction observed in this cohort so far is 98% from a baseline of 157.4 ng/mL.
Clarity has worked closely with global medical experts to optimize its prostate cancer treatment pipeline. Recent protocol amendments to the SECuRE trial include increasing the cohort expansion phase to 24 patients in the pre-chemotherapy setting, with a subset receiving combination therapy with enzalutamide.
Clarity is committed to prioritizing this development to improve treatment outcomes for people with cancer.
Source: claritypharmaceuticals.com
