Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging
The FDA granted Fast Track designation to Telix's BiPASS program, which evaluates gallium-68 PSMA-PET imaging alongside MRI for pre-biopsy prostate cancer detection. The designation enables more frequent FDA engagement and may expedite review of the planned NDA; Telix recently completed enrollment in the Phase 3 BiPASS study using its approved agents Illuccix and Gozellix.
Key figures
- Drug Name
- BiPASS ((68)Ga-PSMA-PET imaging with Illuccix and Gozellix)
- Phase Of Trial
- Phase 3
- Negative biopsy rate
- up to 75%
- Unnecessary biopsy reduction
- almost 50 percent
- Annual prostate biopsies global
- more than three million
AI analysis
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