Telix's pre-biopsy PSMA-PET program gets FDA Fast Track designation

The FDA granted Fast Track to Telix’s BiPASS program evaluating gallium-68 PSMA-PET + MRI before prostate biopsy. The goal: improve detection of clinically significant cancer and reduce unnecessary biopsies by nearly 50%.

• The BiPASS phase 3 study builds on evidence that adding gallium-68 PSMA-PET to MRI can reduce unnecessary prostate biopsies by nearly 50%.
• More than 3 million prostate biopsies are performed globally each year, with up to 75% yielding negative results.
• Fast Track designation allows more frequent FDA interaction as Telix prepares a New Drug Application.

Automated summary

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