67Cu-SAR-bisPSMA: FDA status

No recent update Indication: PSMA positive metastatic castration resistant prostate cancer previously treated with androgen receptor pathway inhibitor. Company: Clarity Pharmaceuticals.

Regulatory history

• Feb 19, 2025: Breakthrough designation. FDA granted fast track designation to 67Cu SAR bisPSMA for mCRPC patients previously treated with an androgen receptor pathway inhibitor urologytimes.com

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