Telix gets FDA Fast Track for BiPASS pre-biopsy prostate imaging program

Telix Pharmaceuticals Limited announced on September 30, 2026 that the U.S. Food and Drug Administration had granted Fast Track designation for the Company's BiPASS® program.¹ BiPASS (Biopsy of the Prostate Avoidance Stratification Study) is evaluating gallium-68 (68Ga) PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy.¹

Telix said more than three million prostate biopsies are performed globally each year, yet up to 75% produce a negative result, and biopsy can be stressful and painful for patients while sometimes providing no meaningful diagnostic benefit.¹

The company said it recently completed enrollment in the Phase 3 BiPASS study of its proprietary 68Ga-PSMA-PET agents, Illuccix® and Gozellix®, for pre-biopsy prostate cancer diagnosis.¹ Telix said it has positively engaged with the FDA on a new drug application (NDA) pathway and is planning its submission.¹

According to Telix, the BiPASS program builds on earlier work from the PRIMARY and PRIMARY2 studies.¹ The company said those studies showed that pairing PSMA-PET imaging with MRI could sharpen detection of significant prostate cancer while cutting unneeded biopsies nearly in half, according to the release.

Telix described BiPASS as intended to complement rather than eliminate biopsy, aiming instead to help clinicians decide which patients need one and where it should be targeted, per the company.

Illuccix and Gozellix currently hold FDA approval for PET imaging of PSMA-positive lesions in prostate cancer patients with suspected metastasis who are candidates for initial definitive therapy, and in patients with suspected recurrence based on elevated PSA, with Illuccix also approved for selecting patients for PSMA-directed therapy.¹ The filing noted that use of Illuccix and Gozellix in the pre-biopsy setting remains investigational and has not been approved by the FDA or any other regulatory authority.¹