FDA Fast Track for BiPASS Pre Biopsy Prostate Imaging

Key points

• FDA Fast Track designation for BiPASS program
• Aims to improve prostate cancer diagnostic pathway
• Potential to reduce unnecessary biopsies

Full summary

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for its BiPASS program. This program evaluates gallium-68 (68Ga) PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy. The Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, potentially accelerating patient access if approved. The BiPASS program builds on the clinical foundation established by the PRIMARY and PRIMARY2 studies, which demonstrated that combining 68Ga-PSMA-PET imaging with MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent.