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PET Agent Receives FDA Fast Track Designation for mCRPC
The PET radiopharmaceutical SAR-bisPSMA has garnered three FDA fast track designations in a six-month period for use in the detection and management of prostate cancer.
The Food and Drug Administration (FDA) has granted a fast track designation for the positron emission tomography (PET) agent 67Cu-SAR-bisPSMA for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor pathway inhibitors (ARPIs).
Clarity Pharmaceuticals, the developer of 67Cu-SAR-bisPSMA, noted the fast track designation was based on preliminary data from the ongoing phase I/IIa SECuRE study of the PET agent.
In a cohort of patients with high baseline prostate-specific antigen (PSA) levels (median of 112.86 ng/mL), 77 percent of whom had bone metastasis, the use of 67Cu-SAR-bisPSMA resulted in PSA reductions for 73 percent of patients, according to Clarity Pharmaceuticals.
In preliminary data from the ongoing phase I/IIa SECuRE study, the PET agent 67Cu-SAR-bisPSMA reportedly achieved PSA level reductions in 73 percent of patients with metastatic castration-resistant prostate cancer (mCRPC), 77 percent of whom had bone metastasis, according to Clarity Pharmaceuticals, the developer of the PET agent. (Image courtesy of Adobe Stock.)
Noting that 59 percent of the cohort had received three or more previous lines of therapy, the company said 45 percent of the SECuRE trial participants have had greater than 50 percent reductions in PSA levels.
(Editor’s note: For related content on prostate cancer imaging, click here.)
Clarity Pharmaceuticals said the current FDA fast track designation follows two prior fast track designations for the diagnostic version of the SAR-bisPSMA radiopharmaceutical (64Cu-SAR-bisPSMA).
“Receiving 3 FTDs for the one molecule, SAR-bisPSMA, within the last six months is an incredible achievement for Clarity, highlighting how impressive our science and development are, the significance of the diagnostic and therapeutic data so far, and the high unmet need for better therapies and diagnostics in prostate cancer,” noted Alan Taylor, Ph.D., the executive chairperson for Clarity Pharmaceuticals.
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