Selbion receives Phase 3 approval for prostate cancer drug

Selbion, a radiopharmaceutical specialist, has received approval from South Korea’s Ministry of Food and Drug Safety to conduct Phase 3 clinical trials for its prostate cancer drug candidate, 177Lu-DGUL (pucobotide satetrasetane).

The trial targets patients with metastatic castration-resistant prostate cancer (mCRPC). It is designed as a multicenter, randomized, open-label study involving 150 patients. The study will compare the efficacy and safety of 177Lu-DGUL when administered alongside best supportive care (BSC) or standard of care (SoC) against a control group receiving only BSC/SoC.

The primary endpoint is radiographic progression-free survival (rPFS). The clinical trial is expected to take approximately 36 months, with a projected completion date in early 2030. The drug works by targeting prostate-specific membrane antigen (PSMA).