Telix wins FDA Fast Track for BiPASS pre-biopsy prostate cancer imaging study
TLX•Telix received FDA Fast Track designation for BiPASS, a Phase 3 program testing 68Ga PSMA-PET with MRI before prostate biopsy. Enrollment is complete, but no trial results were reported.
1. Fast Track designation
Telix received FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga PSMA-PET with MRI before prostate biopsy. Enrollment is complete. The designation increases FDA interaction and may support an accelerated review timetable for a planned NDA submission.
2. Pre-biopsy use remains investigational
The program aims to reduce unnecessary biopsies while improving identification of clinically significant prostate cancer. Illuccix and Gozellix remain investigational for pre-biopsy use, despite approvals in other prostate cancer imaging settings.
