FDA Grants Fast Track Designation for Pre-Biopsy Use of PSMA PET and MRI for Prostate Cancer Detection

The Food and Drug Administration (FDA) has issued a fast track designation for a pre-biopsy combination of ⁶⁸Ga PSMA PET and prostate MRI that has demonstrated the capability to facilitate a nearly 50 percent reduction in unnecessary prostate biopsies.

Reportedly up to 75 percent of the more than three million prostate biopsies performed worldwide have negative results, according to Telix Pharmaceuticals.

Findings from a recently published phase 3 multicenter randomized controlled trial (PRIMARY2) revealed that the use of ⁶⁸Ga PSMA PET/CT reduced prostate biopsies by 49 percent in biopsy-naïve men with PI-RADS 2 or 3 MRI findings and at least one clinical risk factor for prostate cancer (PCa).

Enrollment has recently been completed for a phase 3 study (BiPASS) that will assess the pre-biopsy use of the ⁶⁸Ga PSMA PET agents Illuccix and Gozellix alongside prostate MRI for PCa detection, according to Telix Pharmaceuticals.

"Fast track designation reflects the FDA's recognition of the potential for BiPASS to address an important unmet need in the prostate cancer diagnostic pathway. We believe gallium-68 PSMA-PET, used alongside MRI, could help physicians make more informed decisions before biopsy, improve diagnostic confidence and potentially reduce unnecessary invasive procedures for patients,” noted David N. Cade, MBBS, MBA, the group chief medical officer for Telix Pharmaceuticals.