Pre-Biopsy PSMA PET/MRI Gains FDA Fast Track Designation, Phase 3 Trial Enrolled

FDA has granted Fast Track designation for a pre-biopsy diagnostic pathway combining 68Ga-PSMA PET and prostate MRI, reportedly capable of reducing unnecessary biopsies by nearly 50%. Enrollment is complete for the phase 3 BiPASS trial evaluating Illuccix and Gozellix alongside…

• The FDA Fast Track designation applies to the BiPASS program, which uses 68Ga-PSMA PET and MRI before prostate biopsy.
• According to Telix Pharmaceuticals, the approach has shown the potential to cut unnecessary biopsies by almost half.
• The phase 3 study will assess the combination using the PSMA-PET agents Illuccix and Gozellix.

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